Note: Descriptions are shown in the official language in which they were submitted.
CA 02794919 2012-11-13
FORMULATIONS AND METHODS FOR PREVENTING EYEBROW HAIR LOSS
BACKGROUND
[0001] Hair is composed of keratin, a tough and insoluble protein. Each
individual
hair comprises a cylindrical shaft and a root, and is contained in a follicle,
a flask-like
depression in the skin. The bottom of the follicle contains a finger-like
projection termed the
papilla, which consists of connective tissue from which hair grows, and
through which blood
vessels supply the cells with nourishment. The shaft is the part of the hair
that extends
outwards from the skin surface, and the root is the part of the hair that
remains buried beneath
the skin surface. The base of the root expands into a hair bulb, which rests
upon the papilla.
Cells from which the hair is produced grow in the bulb of the follicle and are
extruded in the
form of fibers as the cells proliferate in the follicle. "Hair growth" refers
to the formation and
elongation of the hair fiber by the dividing cells.
[0002] Hair growth occurs by a cycle of activity that is divided into three
stages:
anagen, catagen, and telogen. Anagen is the active phase, during which the
epidermal stem
cells of the dermal papilla divide rapidly. Daughter cells move upward and
differentiate to
form the concentric layers of the hair itself. Catagen is the transitional
stage, where follicular
stem cell division has ceased. Telogen is the resting stage, where the hair is
retained for
several weeks before an emerging new hair developing below it dislodges the
telogen-phase
shaft from its follicle. Hair is thus undergoing constant renewal. Among
approximately
125,000-150,000 hairs on a scalp, at any given time approximately ten percent
are at rest and
will be replaced within a few months.
[0003] The location in which hair originates affects its characteristics.
Eyebrow
hair, for example, differs from scalp hair in several respects. For eyebrow
hair, the growth
cycle is very short, typically completing in approximately 4 months, whereas
the scalp hair
growth cycle requires 3 to 4 years to complete. This difference in growth
cycle duration is
the reason eyebrow hairs are much shorter than scalp hairs. Another
distinction is that
eyebrow hair emerges from the follicle at a very acute angle, which produces
growth that is
essentially parallel to the skin surface. By contrast, the angle between scalp
hair and the skin
can be 45 degrees or more. Eyebrow hairs also grow as single strands, whereas
several hair
strands typically arise from a single follicle on the scalp.
[0004] Disruption of the hair growth cycle causes alopecia (hair loss), a
condition
that affects millions of men and women. Alopecia encompasses any loss of hair,
including
not only from the scalp, but also from other areas such as the eyebrows. Black
cohosh has
been used to prevent scalp hair loss caused by androgenic alopecia. For
example, Siedel,
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Cimicifuga for the prevention of hair loss, Pharmazeutische Zeitung (18 Sept
2003) Vol.
148, No. 38 teaches the use of an unspecified amount of black cohosh for hair
loss due to
androgenic alopecia. However, Siedel does not teach the use of black cohosh to
reduce the
loss of eyebrow hair, which is different from scalp hair in that it has a
shorter growth cycle,
it grows at a different angle, and it grows as single strands.
[0005] Certain chemotherapeutic agents can induce alopecia. Chemotherapy works
by damaging the structure or metabolism of rapidly dividing cells.
Unfortunately,
chemotherapeutic agents do not selectively target only diseased or otherwise
undesirable
cells, such as the rapidly proliferating tissue of a cancerous tumor, and
instead also attack
normal cells that multiply rapidly in the body, including those in bone
marrow, the lining of
the mouth, stomach, and hair follicles.
[0006] Due to its long anagen phase, the scalp is a common location for
chemotherapy-induced hair loss. Hairs of the beard, eyebrows, eyelashes,
axillary regions,
and pubic regions are also variably affected by chemotherapy. During anagen,
cells in the
bulb of the hair follicle exhibit the greatest activity in building up the
hair shaft.
Chemotherapeutic agents impair mitotic and metabolic processes in actively
growing hair
follicles and lead to a weakening of the partially keratinized, proximal
portion of the hair
shaft, resulting in a thinning of the hair shaft, which becomes fragile and
susceptible to
breakage with minimal influence (anagen effluvium). Evidence exists suggesting
that telogen
hair is also lost during chemotherapy (telogen effluvium). Braun-Falco,
Dynamics of normal
and pathological hair growth, ARCH. KL1N. EXP. DERMATOL. 227(1):419-52 (1966).
[0007] In human skin, alopecia can start at any time after initiation of
chemotherapy,
but hair loss typically occurs 2 to 4 weeks after treatment begins. Hubbard,
Chemotherapy-
induced alopecia, CLIN. ONCOL. 4:387-457 (1985); Hussein, Chemotherapy-induced
alopecia:
New developments, SOUTHERN MED. J. 86:489-496 (1993). The rate and pattern of
hair
shedding varies with the degree to which anagen effluvium and telogen
effluvium occur.
Accordingly, the hair may fall out very quickly in clumps or it may fall out
gradually.
[0008] The extent of chemotherapy-induced hair loss depends on the drug being
used, how long the drug is used, and whether other treatments (such as
radiation) are
concurrently employed. There are four major classes of chemotherapeutic agents
that can
induce alopecia, with the extent of induced hair loss differing across the
classes:
antimicrotubule agents (e.g. paclitaxel (trade name Taxol )); topoisomerase
inhibitors (e.g.
doxorubicin); alkylators (e.g. cyclophosphamide); and antimetabolites (e.g. 5-
fluorouracil
plus leucovorin). Drugs with high potential for inducing alopecia include
adriamycin,
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cyclophosphamide daunorubicin, docetaxel (trade name Taxotere), epirubicin,
etoposide,
ifosphamide, irinotecan, paclitaxel, topotecan, vindesine, and vinorelbine.
Taxol typically
induces complete hair loss, including scalp and eyebrows. Adriamycin causes
complete hair
loss on the scalp, and very often causes loss of eyebrows in patients.
Chemotherapeutic
agents such as methotrexate, cytoxan, carboplatin, and 5-fluorouracil can
cause hair loss in
some patients but not others. There are many similar examples of
chemotherapeutic agents
that can induce partial or complete hair loss in various locations throughout
the body. The
overall incidence of chemotherapy-induced hair loss is estimated to be 65
percent. Trueb,
Chemotherapy-induced alopecia, SEMIN. CUTAN. MED. SURG. 28(1):11-14 (2009).
[0009] Chemotherapy-induced alopecia can be profoundly traumatic, and ranks
among the most psychologically devastating side-effects of cancer treatment.
Kiebert et al.
Effect of perioperative chemotherapy on the quality of life of patients with
early breast
cancer, EUR. J. CANCER 26:1038-1042 (1990); Macquart-Moulin et al. Discordance
between
physicians' estimations and breast cancer patients' self-assessments of side-
effects of
chemotherapy: an issue for quality of care, BR. J. CANCER 76:1640-1645 (1997).
Indeed,
studies show that for many women, losing their hair is more emotionally
distressing than
losing a breast, because one can conceal loss of a breast but hair loss is so
obvious and
apparent. For men as well, hair loss during chemotherapy can negatively affect
perceptions
of masculinity, and loss of eyebrows in particular provides an unwelcome
signal of having
cancer. More than 80 percent of patients who receive chemotherapy consider
hair loss to be
the worst aspect of their treatment (Kiebert et al.; Macquart-Moulin et al.),
and 8 percent of
female cancer patients would even decline treatment for fear of that side-
effect. McGarvey et
al., Psychological sequelae and alopecia among women with cancer, CANCER
PRACT.
9(6):283-289 (2001); Munstedt et al., Changes in self-concept and body image
during
alopecia induced cancer chemotherapy, SUPPORT CARE CANCER 5(2):139-143 (1997).
Although cranial prostheses (wigs) sometimes can be used to conceal loss of
scalp hair, it is
far more difficult to conceal loss of other facial hair, such as eyebrows.
Eyebrows are a
critical facial feature that serve to frame the eyes (the single most
important facial element)
and they convey key non-verbal information.
[0010] Though the structure and growth cycle of hair is well known, the exact
mechanism(s) by which chemotherapeutic agents cause hair loss is not well
understood.
Although morphological changes that occur in hair follicles during
chemotherapy were
initially described in the early 1960s, there has been little progress in
elucidating the
mechanism(s) underlying such morphological changes.
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[0011] Several diverse measures have been suggested for limiting or preventing
chemotherapy-induced alopecia. Some researchers suggest that massive induction
of
apoptosis (a process of programmed cell death (PCD) that may occur in multi-
cellular
organisms) in the hair follicle is one mechanism by which chemotherapeutic
agents damage
growing hair follicles. These researchers propose that a pretreatment with
topical calcitriol-
analogs can suppress chemotherapy-induced apoptosis in vivo. Schilli et al.,
Reduction of
Intrafollicular Apoptosis in Chemotherapy-Induced Alopecia by Topical
Calcitriol-Analogs,
J. INVESTIGATIVE DERM. 111:598-604 (1998). However, topical application of
1,25-
dihydroxyvitamin D3 failed to prevent or retard hair loss in human scalp after
administration
of cyclophopshamide. Hidalgo et al., A phase I trial of topical topitriol
(calcitriol, 1,25-
dihidroxyvitamin D3) to prevent chemotherapy-induced alopecia, ANTICANCER
DRUGS
10:393-395 (1999).
[0012] Other investigators suggest that cleansing follicle openings of sebum
may
reduce hair loss and reduce the time necessary for hair re-growth in cancer
patients who
undergo chemotherapy. For example, U.S. Patent No. 6,139,828 to McCullough
discloses
compositions for cleansing the scalp and hair follicles. However, the
disclosed compositions
include anionic surfactants, which can be harsh and irritating. Moreover, the
disclosure
provides only a single example of use of the claimed compositions in a patient
undergoing
chemotherapy. Though that example suggests that the patient experienced hair
re-growth
while continuing chemotherapy and radiation treatments, the disclosure
provides no
information regarding the patient's previous or current chemotherapy regimen.
Because
certain chemotherapeutic agents do not cause hair loss, it is not clear
whether that patient
experienced hair re-growth due to application of the disclosed composition, or
instead simply
due to natural hair re-growth where the presently-employed chemotherapeutic
agent was one
that did not induce hair loss. Furthermore, the disclosure nowhere discusses
or exemplifies
preventing (as opposed to reducing) hair loss in chemotherapy patients, and
nowhere
discusses or exemplifies reducing or preventing eyebrow loss.
[0013] Still other researchers suggest that scalp cooling may be effective in
preventing hair loss in patients treated with certain chemotherapeutic agents.
Such
proponents contend that cooling the scalp to a temperature that produces a
subcutaneous
temperature of 20 C (68 F) constricts blood supply to hair follicles,
preventing high
chemotherapy dose delivery during the initial phase of treatment, and reducing
metabolic rate
of hair follicle cells. However, such treatment can be uncomfortable for a
patient to endure.
Moreover, scalp cooling does not prevent loss of other facial hair, such as
eyebrows.
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[0014] Still further methods that do not interact directly with existing hair
follicles
have also been proposed for concealing hair loss, and in particular eyebrow
loss. For
example, micropigmentation (tattooing) is sometimes used to simulate eyebrows
that have
been permanently lost. Micrograft transplants can also sometimes be used to
restore
eyebrows. However, such methods are time-consuming, often painful, and
expensive.
[0015] As the discussion above demonstrates, previously proposed treatments
for
preventing chemotherapy-induced hair loss are uncertain and unsatisfactory in
many respects.
So far, no satisfactory composition or method exists for limiting or
preventing chemotherapy-
induced alopecia in humans. Accordingly, there remains a need for compositions
and
methods for preventing hair loss in patients undergoing chemotherapy, and in
particular for
preventing eyebrow loss in such patients.
SUMMARY
[0016] In one aspect, the present invention provides a composition for
reducing loss
of eyebrow hair in chemotherapy patients, comprising from about 2 to about 40
percent by
weight of black cohosh extract, from about 0.5 to about 20 percent by weight
of nonionic
surfactant, and from about to 40 about 97.5 percent by weight of hydroxylated
solvent.
[0017] In another aspect, the present invention provides a composition for
reducing
loss of eyebrow hair in chemotherapy patients, comprising from about 4 to
about 40 percent
by weight of black cohosh extract, from about 0.5 to about 20 percent by
weight of nonionic
surfactant, and from about 40 to about 95.5 percent by weight of hydroxylated
solvent.
[0018] In another aspect, the present invention provides a composition for
reducing
loss of eyebrow hair in chemotherapy patients, comprising from about 5 to
about 40 percent
by weight of black cohosh extract, from about 0.5 to about 20 percent by
weight of nonionic
surfactant, and from about 40 to about 94.5 percent by weight of hydroxylated
solvent.
[0019] In another aspect, the present invention provides a composition,
comprising
from about 2 to about 40 percent by weight of black cohosh extract, from about
0.5 to about
20 percent by weight of nonionic surfactant, and from about 40 to about 97.5
percent by
weight of hydroxylated solvent.
[0020] In another aspect, the present invention provides a composition
comprising
from about 4 to about 40 percent by weight of black cohosh extract, from about
0.5 to about
20 percent by weight of nonionic surfactant, and from about 40 to about 95.5
percent by
weight of hydroxylated solvent.
[0021] In yet another aspect, the present invention provides a composition
comprising from about 5 to about 40 percent by weight of black cohosh extract,
from about
CA 02794919 2012-11-13
0.5 to about 20 percent by weight of nonionic surfactant, and from about 40 to
about 94.5
percent by weight of hydroxylated solvent.
[0022] In another aspect, the present invention provides a composition for
reducing
loss of eyebrow hair in chemotherapy patients, comprising from about 15 to
about 30
percent by weight of a 20-percent solution of black cohosh extract in
hydroxylated solvent,
from about 1 to about 10 percent by weight polysorbate 20, from about 10 to
about 20
percent by weight isopropanol, and from about 40 to about 75 percent by weight
water.
[0023] In another aspect, the present invention provides a composition,
comprising
from about 15 to about 30 percent by weight of a 20-percent solution of black
cohosh extract
in hydroxylated solvent, from about 1 to about 10 percent by weight
polysorbate 20, from
about 10 to about 20 percent by weight isopropanol, and from about 40 to about
75 percent
by weight water.
[0024] In yet another aspect, the present invention provides a composition
having a
pH of from about 4 to about 8.
[0025] In another aspect, the present invention provides a composition having
a pH
of from about 5 to about 6.
[0026] In another aspect, the present invention provides a composition having
a pH
of from about 7 to about 8.
[0027] In yet another aspect, the present invention provides a composition
comprising a nonionic surfactant, wherein the nonionic surfactant comprises a
polyoxyethylene derivative of sorbitan monolaurate.
[0028] In another aspect, the present invention provides a composition
comprising a
polyoxyethylene derivative of sorbitan monolaurate, wherein the
polyoxyethylene derivative
of sorbitan monolaurate is polysorbate 20.
[0029] In another aspect, the present invention provides a composition
comprising a
nonionic surfactant, wherein the nonionic surfactant comprises a mixture of at
least two
nonionic surfactants.
[0030] In another aspect, the present invention provides a composition
comprising a
nonionic surfactant, wherein the nonionic surfactant comprises a mixture of
polysorbate 20
and at least one other nonionic surfactant.
[0031] In yet another aspect, the present invention provides a composition
comprising a hydroxylated solvent, wherein the hydroxylated solvent is water.
[0032] In another aspect, the present invention provides a composition
comprising a
hydroxylated solvent, wherein the hydroxylated solvent comprises a monohydric
alcohol.
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[0033] In another aspect, the present invention provides a composition
comprising a
monohydric alcohol, wherein the monohydric alcohol comprises a C1 to C6
alcohol.
[0034] In another aspect, the present invention provides a composition
comprising a
hydroxylated solvent, wherein the hydroxylated solvent comprises a polyhydric
alcohol.
[0035] In another aspect, the present invention provides a composition
comprising a
polyhydric alcohol, wherein the polyhydric alcohol is selected from the group
consisting of
ethylene glycol, propylene glycol, glycerol, polyol monoethers, and mixtures
of two or more
thereof.
[0036] In another aspect, the present invention provides a composition
comprising a
hydroxylated solvent, wherein the hydroxylated solvent comprises a mixture of
water and a
monohydric alcohol.
[0037] In another aspect, the present invention provides a composition
comprising a
hydroxylated solvent, wherein the hydroxylated solvent comprises a mixture of
water and a
polyhydric alcohol.
[0038] In another aspect, the present invention provides a composition
comprising a
hydroxylated solvent, wherein the hydroxylated solvent comprises a mixture of
water, a
monohydric alcohol, and a polyhydric alcohol.
[0039] In another aspect, the present invention provides a composition
comprising a
monohydric alcohol, wherein the monohydric alcohol is isopropanol.
[0040] In another aspect, the present invention provides a composition
comprising a
polyhydric alcohol, wherein the polyhydric alcohol is propylene glycol.
[0041] In another aspect, the present invention provides use of a composition
for
reducing loss of eyebrow hair in chemotherapy patients.
[0042] In another aspect, the present invention provides a method for treating
hair
loss comprising use of a composition comprising from about 2 to about 40
percent by weight
of black cohosh extract, from about 0.5 to about 20 percent by weight of
nonionic surfactant,
and from about to 40 about 97.5 percent by weight of hydroxylated solvent.
[0043] In yet another aspect, the invention provides a method for reducing or
preventing loss of eyebrows in chemotherapy patients, comprising use of a
composition
comprising from about 2 to about 40 percent by weight of black cohosh extract,
from about
0.5 to about 20 percent by weight of nonionic surfactant, and from about to 40
about 97.5
percent by weight of hydroxylated solvent.
[0044] Embodiments of the present invention may pertain to one or more of
these
aspects, or to other aspects disclosed herein. These and other aspects and
advantages of the
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CA 02794919 2012-11-13
present invention will be apparent to those of ordinary skill in the art from
the disclosure
herein, and in particular from the following detailed description of the
invention.
DETAILED DESCRIPTION
[0045] It has been surprisingly found that certain compositions containing
black
cohosh extract are effective in reducing and preventing hair loss,
particularly the loss of
eyebrows, in patients undergoing chemotherapy. Compositions of the present
invention
comprise from about 2 to about 40 percent by weight of black cohosh extract,
from about 0.5
to about 20 percent by weight of nonionic surfactant, and from about to 40
about 97.5 percent
by weight of hydroxylated solvent. The compositions disclosed herein may also
optionally
include one or more additives. Compositions of the invention may be in any
form suitable
for topical administration, including but not limited to liquids, gels,
pastes, or emulsions.
Black Cohosh
[0046] As used herein, the term "black cohosh extract" refers to an extract
from one
or more portions of the black cohosh plant, or to a solution containing an
equivalent amount
of the active ingredient(s) thereof. As used herein, the term "extract" refers
to a concentrate
of water-soluble and/or alcohol-soluble plant components from the portion of
the plant
extracted.
[0047] Black cohosh has peripheral vasodilatory and anti-inflammatory effects.
The
roots and rhizomes (underground stems) of black cohosh were long used
medicinally by
Native Americans to treat a host of conditions, including gynecological
disorders, kidney
disorders, malaria, and rheumatism. "Cohosh" is the Algonquin word for "gnarly
root."
Historically, black cohosh has been used as an anti-inflammatory and sedative
in treating
female reproductive complaints such as painful menstrual cramping, delayed
periods,
mastitis, ovarian pain and other menopausal symptoms. In the present day,
black cohosh is
most commonly used as a remedy for rheumatoid and myalgic pain, to control
symptoms of
menopause, and as an alternative to hormone replacement therapy with patients
for whom
such therapy is either refused or contraindicated. For example, U.S. Patent
No. 7,179,494 to
Marchese et al. discusses using 0.473% Chinese black cohosh extract for
reducing incidents
of hot flashes. However, as shown in the Examples below, such an amount of
black cohosh
would be ineffective for preventing or reducing the loss of eyebrow hair in
chemotherapy
patients.
[0048] Black cohosh is a member of the botanical family Ranunculaceae
(buttercup
family), and is a perennial plant native to temperate regions of the Northern
Hemisphere.
The taxonomic genus of the plant species black cohosh is a matter of dispute.
In the
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CA 02794919 2012-11-13
eighteenth century, the Swedish botanist Carl Linnaeus classified the species
within the genus
Actaea. This designation was revised in the nineteenth century by the English
botanist
Thomas Nuttall, who reclassified the species into the genus Cimicifuga. Recent
data from
morphological and gene phylogeny analyses suggest that black cohosh is more
closely related
to species of the genus Actaea than to other Cimicifuga species, prompting
some botanists to
revise the black cohosh genus classification to Actaea racemosa as originally
proposed by
Linnaeus. Scientific debate regarding the proper taxonomic designation for
black cohosh
continues to this day. Accordingly, black cohosh is known as both Actaea
racemosa and
Cimicifuga racemosa. Other common names include baneberry, black snakeroot,
black
bugbane, bugbane, bugwort, fairy candle, macrotys, rattleroot, rattletop,
rattleweed, and
squawroot. Insects avoid the black cohosh plant, which accounts for some of
its common
names.
[0049] The genus Cimicifuga includes eighteen species, one of which is native
to
Europe, six of which are native to North America, and the remainder of which
are native to
northeast Asia. The genera Actaea and Cimicifuga when combined include 25 to
30 species.
Thus, the black cohosh genus contains numerous species, and any suitable black
cohosh plant
within the black cohosh genus can be used as the source of the black cohosh
extract used in
compositions of the present invention.
[0050] The mechanism of action of black cohosh extract remains unclear. The
chief
constituent of black cohosh root is an amorphous resinous substance known as
Cimicifugin or
Macrotin. Studies show that black cohosh extract contains several compounds
that may
contribute to its activity, including triterpene glycosides (acetin,
cimicifugoside, 26-
deoxyactein), isoflavones (formononetin), organic acids (caffeic acid,
fukinolic acid,
isoferulic acid, salicylic acid), aglycones, resins (cimicifugin), phenols,
and antioxidants
(hydroxytyrosol). The biological activity of black cohosh cannot as yet be
attributed to any
one chemical component or group of components.
[0051] Black cohosh extract used in compositions of the present invention can
be
obtained from one or more portions of the black cohosh plant. In the present
invention, the
black cohosh extract is preferably taken from the root and rhizome of the
plant. The black
cohosh plant can be prepared for extraction by subdividing the plant into
small pieces. The
small pieces are ground into a powder form, such as by mechanical disruption
in a blender or
other similar means. If less than the whole plant is being used, the desired
portions are first
isolated from the remaining portions of the plant and then subdivided into
small pieces and
ground into a powder form.
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CA 02794919 2015-10-15
[0052] Black cohosh extract can be prepared using either conventional or
supercritical extraction techniques. Suitable supercritical extraction methods
are disclosed in
U.S. Patent Nos. 5,932,101 and 5,120,558.
Suitable conventional extraction techniques are disclosed in U.S. Patent Nos.
5,891,440, 5,874,084, and 5,908,628. A
preferred method is extraction with a lower alkyl alcohol. A preferred lower
alkyl alcohol is
isopropanol. The resulting extract may be maintained as a liquid or converted
using
conventional means to another form, such as a dried powder for later
reconstitution. In some
instances, black cohosh extract may be supplied as an aqueous solution. In
other instances,
black cohosh extract may be supplied as a solution of water and an alcohol
such as
isopropanol. In still other instances, black cohosh extract may be supplied as
a solution of
water and a hydroxylated solvent such as propylene glycol. Extracts of black
cohosh are
typically standardized to 26-deoxyactein content, and commercial preparations
of black
cohosh usually contain 1 mg of total triterpenes (expressed as 26-deoxyactein)
in each 20-mg
dose of extract.
[0053] Compositions of the invention may contain from about 0.5 to about 40
percent by weight of black cohosh extract, and more particularly from about 2
to about 35
percent by weight of black cohosh extract. More preferably, compositions of
the invention
contain from about 4 to about 25 percent by weight black cohosh extract. A
preferred black
cohosh extract is a 20-percent solution of Cimicifuga racemosa root extract in
a propylene
glycol/water mixture, but others may be used as well.
Nonionic Surfactant
[0054] As used herein, the term "nonionic surfactant" refers to any surfactant
lacking
a charge in its hydrophilic portion. Also as used herein, the term "nonionic
surfactant" refers
to any suitable nonionic surfactant or mixture of two or more nonionic
surfactants.
[0055] Nonionic surfactants are well known in the art, and the present
invention may
employ any nonionic surfactant or mixture thereof that is suitable for
application to skin or
hair and is compatible with other ingredients present in the composition.
Suitable nonionic
surfactants are described in McCutcheon's, Detergents and Emulsifiers, North
American
edition (1986), published by allured Publishing Corporation; McCutchcon's,
Functional
Materials, North American Edition (1992); International Cosmetic Ingredient
Dictionary and
handbook, 71h ed. (1997), published by the Cosmetic, Toiletry, and Fragrance
Association;
and U.S. Pat. No. 3,929,678 issued to Laughlin, et al on Dec. 30, 1975.
CA 02794919 2012-11-13
[0056] Most commonly, nonionic surfactants are compounds produced by the
condensation of an alkylene oxide (hydrophilic in nature) with an organic
hydrophobic
compound which is usually aliphatic or alkyl aromatic in nature. The length of
the
hydrophilic or polyoxyalkylene moiety which is condensed with any particular
hydrophobic
compound can be readily adjusted to yield a water-soluble compound having the
desired
degree of balance between hydrophilic and hydrophobic elements. Another
variety of
nonionic surfactant is the semi-polar nonionic typified by the amine oxides,
phosphine
oxides, and sulfoxides.
[0057] Non-limiting examples of nonionic surfactants suitable for use in the
present
invention include fatty alcohols (including but not limited to cetyl alcohol,
stearyl alcohol,
cetostearyl alcohol, and ley] alcohol); polyoxyethylene glycol alkly ethers
(including but not
limited to polyoxyethylene lauryl ether (Brij 35)); polyoxypropylene glycol
alkyl ethers;
glucoside alkyl ethers; polyoxyethylene glycol octylpohenol ethers (including
but not limited
to Triton X-100); polyoxyethylene glycol alkylphenol ethers (including but
not limited to
nonoxyno1-9); glycerol alkyl esters; polyoxyethylene glycol sorbitan alkyl
esters (including
but not limited to polysorbate-20 and polysorbate-80); sorbitan alkyl esters
(including but not
limited to Span -20 and Span -80); block copolymers of polyethylene glycol and
polypropylene glycol (including but not limited to poloxamer-407); amine
oxides; and
sulfoxides.
[0058] Preferred nonionic surfactants for use in compositions of the present
invention are polyoxyethylene glycol sorbitan alkyl esters. Most preferably,
the nonionic
surfactant is a polyoxyethylene derivative of sorbitan monolaurate such as
polysorbate 20.
The compositions of the invention may contain from about 0.5 to about 20
percent by weight
of a nonionic surfactant, and more particularly from about 1 to about 10
percent by weight of
a nonionic surfactant. More preferably, compositions of the invention contain
from about 4
to about 6 percent by weight of a nonionic surfactant.
flvdroxvlated Solvent
[0059] Compositions of the present invention include one or more hydroxylated
solvents. As used herein, the term "hydroxylated solvent" refers to any
solvent or mixture of
solvents containing at least one hydroxyl group. Suitable hydroxylated
solvents include
water, monohydric alcohols, polyhydric alcohols, or mixtures thereof. Water is
a preferred
hydroxylated solvent.
[0060] Monohydric alcohols that may be used in compositions of the present
invention include but are not limited to C1 to C6 alcohols. Preferred
monohydric alcohols
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CA 02794919 2012-11-13
include methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, t-
butanol, and
mixtures thereof. Isopropanol is a preferred monohydric alcohol.
[0061] Polyhydric alcohols that may be used in compositions of the present
invention include but are not limited to glycols such as ethylene glycol,
propylene glycol,
glycerol, and polyol monoethers. Propylene glycol is a preferred polyhydric
alcohol.
[0062] Preferably, the hydroxylated solvent comprises a mixture of water and a
monohydric alcohol, or a mixture of water and a polyhydric alcohol. Most
preferably, the
hydroxylated solvent comprises a mixture of water, a monohydric alcohol, and a
polyhydric
alcohol.
Optional Components
[0063j The compositions of the invention may optionally contain additives, for
example preservatives, colorants, agents to adjust pH, and fragrances. Any of
the many
preservatives well known in the art can be used. Preservatives for use with
the invention
particularly include but are not limited to phenoxyethanol/ethylhexylglycerin,
methylparaben,
and propylparaben. In certain cases, however, it may be desirable to minimize
or eliminate
use of paraben-based preservatives to improve consumer acceptance.
[0064] The pH of the compositions of the invention may be adjusted to maximize
compatibility with skin and/or to increase or decrease the dermal and/or
follicular penetration
of the composition, as appropriate. In certain embodiments, the pH of the
compositions of
the invention is from about 4 to about 8. In other embodiments, it may be from
about 5 to
about 6, or from about 7 to about 8. Any of the many pH-adjusting ingredients
well known in
the art can be used. The pH-adjusting ingredients for use with the invention
particularly
include but are not limited to citric acid and triethanolamine.
[0065] The compositions of the present invention may be used to treat hair,
and may
be administered by any method known in the art. Preferably, the compositions
are
administered directly to the site where reducing or preventing hair loss is
desired. In
particular, the present invention includes methods for reducing or preventing
loss of
eyebrows in chemotherapy patients using a composition as disclosed herein.
[0066] All percentages used herein are by weight unless otherwise specified.
Various embodiments and/or features are disclosed herein. As will be apparent
to the
ordinarily skilled practitioner, all combinations of such embodiments and
features are
possible and many such combinations can result in preferred executions of the
invention.
[0067] The methods and compositions described herein as representative
preferred
embodiments are exemplary and are not intended as limitations on the scope of
the invention.
12
CA 02794919 2015-10-15
[0068] The present invention may be better understood in light of the
following
examples, which are intended for illustration purposes only, and should not be
construed as
limiting the scope of the invention in any way.
Examples
1. Formulations
[0069] Two formulations were prepared by traditional methods known in the art.
The first (known as CELL 1) is as follows:
CELL 1 ¨ Eyebrow Treatment
Ingredient
Function Wt% _____
Water Diluent/Carrier 54.6
--
Isopropanol Diluent/Carrier 15.0
Polysorbate 20 Surfactant 5.0
Actyphyte of Black Cohosh, Supplied as 20% Solution Active Extract 25.0
(Cimicifuga Racemosa Root Extract in Propylene
Glycol/Water)
Euxyl PE 9010 (Phenoxyethanol/Ethylhexylglyeerin) Preservative 0.1
Methylparaben Preservative 0.1
Propylparaben Preservative 0.1
Caramel Color, 1% Prepared from Concentrate "I-Colorant 0.1
Citric Acid pH Adjuster QS pIl 5.0
6.0
[0070] The second formulation (known as CELL 2) is as follows:
CELL 2 ¨ I ,ye brow Treatment
Ingredient Function Wt%
Water Diluent/Carrier 54.6
Isopropanol ________________________________ I Diluent/Carrier 15.0
Polysorbatc 20 1 Surfactant 5.0
13
CA 02794919 2012-11-13
Actyphyte of Black Cohosh, Supplied as 20% Solution Active Extract 25.0
(Cimicifuga Racemosa Root Extract in Propylene
Glycol/Water)
Euxyl PE 9010 (Phenoxyethanol/Ethylhexylglycerin) Preservative 0.1
Methylparaben Preservative 0.1
Propylparaben Preservative 0.1
Caramel Color, 1% Prepared from Concentrate Colorant 0.1
Triethanolamine, 85% pH Adjuster QS pH
8.0
2. Initial Administration of Formulations to Patients
[0071] Efficacy of formulations described herein was evaluated in 9 subjects
undergoing chemotherapy. CELL 1 was used with 4 of the 9 subjects, and CELL 2
was used
with the remaining 5 subjects. Each subject applied the formulation to each
eyebrow twice
daily (morning and evening), starting one week prior to the first chemotherapy
treatment and
continuing for two months after the chemotherapy treatment was completed. The
formulation was applied to eyebrows only.
[0072] Prior to each application of the formulation, the subject cleaned and
completely dried his or her eyebrows. Using a clean cotton swab, the subject
then applied the
formulation to both eyebrows. The formulation was stored at room temperature
in a tightly
closed bottle between usage periods.
[0073] At interim periods and at the conclusion of the chemotherapy treatment,
hair
loss and/or retention was evaluated to assess efficacy of the formulation.
[0074] Data for each subject is summarized in the following examples:
Example 1
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Cytoxan and Taxotere (every three weeks X 4 cycles)
Formulation applied: CELL 2
Final assessment: Eyebrows fully retained, despite complete body hair loss
everywhere
else.
Example 2
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Cytoxan and Taxotere (every three weeks X 4 cycles)
Formulation applied: CELL 1
Final assessment: Eyebrows fully retained, despite complete body hair loss
everywhere
else.
14
CA 02794919 2012-11-13
Example 3
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Cytoxan and Taxotere (every three weeks X 4 cycles)
Formulation applied: CELL 1
Final assessment: Eyebrows
fully retained, despite extensive body hair loss everywhere
else.
Example 4
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Taxotere Cytoxan, and Adriamycin
Formulation applied: CELL 2
Final assessment: Eyebrows
fully retained, despite complete body hair loss everywhere
else.
Example 5
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Adriamycin
and Cytoxan (every 2 weeks X 4 cycles), followed
by Taxol (every 2 weeks X 4 cycles)
Formulation applied: CELL 1
Final assessment: Eyebrows
50% retained, despite complete body hair loss everywhere
else. Subject omitted a few applications of the formulation during the final
evaluation period.
Example 6
Gender: Female
Medical Diagnosis: Bladder cancer
Chemotherapy regimen: Taxol
(every 3 weeks X 3 cycles), followed by Carboplatin
(every 3 weeks X 3 cycles) and Gemzar
Formulation applied: CELL 2
Final assessment: Eyebrows
50% retained, despite complete body hair loss everywhere
else. Subject omitted a few applications of the formulation during the final
evaluation period.
Example 7
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Taxol (4 cycles)
Formulation applied: CELL 1
Final assessment: Eyebrows
fully retained, despite complete body hair loss everywhere
else.
Example 8
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Cytoxan and Taxotere (every three weeks X 6 cycles)
Formulation applied: CELL 2
Final assessment: Eyebrows
fully retained, despite complete body hair loss everywhere
else.
Example 9
CA 02794919 2012-11-13
Gender: Female
Medical Diagnosis: Breast cancer
Chemotherapy regimen: Cytoxan and Adriamycin (every three weeks X 4 cycles)
Formulation applied: CELL 2
Final assessment: Eyebrows fully retained, despite complete body hair loss
everywhere
else.
3. Clinical Study
[0075] Efficacy of formulations with 0.5%, 2%, 5%, and 10% active black cohosh
was evaluated in 121 subjects undergoing chemotherapy. Many chemotherapy drugs
used to
treat cancer patients induce full body hair loss (scalp, eyebrows, eyelashes,
arms, legs, and
pubic hair). Virtually all of the 121 participants in the study underwent
intense chemotherapy
treatment using drugs that typically induce full body hair loss. Each subject
applied the
formulation to each eyebrow twice daily (morning and evening), starting one
week prior to
the first chemotherapy treatment and continuing for two months after
chemotherapy
treatment was completed. The formulation was applied to eyebrows only.
[0076] Prior to each application of the formulation, the subject cleaned and
completely dried his or her eyebrows. Using a clean cotton swab, the subject
then applied the
formulation to both eyebrows. The formulation was stored at room temperature
in a tightly
closed bottle between usage periods.
[0077] At interim periods and at the conclusion of chemotherapy treatment,
hair loss
and/or retention was evaluated to assess efficacy of the formulation.
[0078] Data for each subject is summarized in the following examples:
1. 0.5% Active Black Cohosh Level Formula:
Participant #: 90
Gender: Female
DOB: Age 56
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Herceptin & Taxotere (every 3 weeks)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 17, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 92
Gender: Female
16
CA 02794919 2012-11-13
DOB: 2-16-58
Race: Caucasian
Medical Diagnosis: Lymphoma
Description of Chemotherapy Regimen: Cytoxan & Rituxan (every 3 weeks X 5
cycles),
followed by: Treanda & Rituxan (every 3 weeks X 6 cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 16, 2012
Final Report of Eyebrow Condition: Patient lost 80% of eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 93
Gender: Female
DOB: 11-25-47
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 14, 2012
Final Report of Eyebrow Condition: Patient lost 90% of eyebrows.
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 94
Gender: Female
DOB: 6-3-38
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Ce11# 4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report: November 22, 2011
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient discontinued application of the solution. Incomplete result.
Participant #: 95
Gender: Female
DOB: 11-4-41
Race: Caucasian
Medical Diagnosis: Lung Cancer
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CA 02794919 2012-11-13
Description of Chemotherapy Regimen: Cisplatin & Navelbin (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #4 Formula #: 09091 IC Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 14, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 99
Gender: Female
DOB: 11-16-63
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Taxol (every 2
weeks X
4 cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 17, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 100
Gender: Female
DOB: Breast Cancer
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Carboplatin & Herceptin (every
3
weeks X 6 cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 9, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 104
Gender: Female
DOB: 6-17-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks for 4
months)
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CA 02794919 2012-11-13
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 27, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 105
Gender: Female
DOB: 4-16-51
Race: Caucasian
Medical Diagnosis: Endometrial Cancer
Description of Chemotherapy Regimen: Paclitaxel & Carboplatin (every 3 weeks X
6
cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 6, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Before photo taken (unable to obtain after photo ¨
patient moved)
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 107
Gender: Female
DOB: 8-28-72
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan (every 2 weeks X 4
cycles),
Taxol (every 4 weeks X 4 cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 7, 2012
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including the eyebrows.
Participant #: 1 I 2
Gender: Female
DOB: 7-13-46
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
19
CA 02794919 2012-11-13
Follow-up Evaluations: Periodically
Date of Final Report: May 21, 2012
Final Report of Eyebrow Condition: Patient lost approximately 60% of eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss, including 60% of the
eyebrows.
Participant #: 114
Gender: Female
DOB: 9-1-64
Race: Caucasian
Medical Diagnosis: Leukemia
Description of Chemotherapy Regimen: Rituxan, Fludara & Cytoxan (every 4 weeks
X 8
cycles)
Inventive Solution Used: Cell #4 Formula #: 090911C Batch #: 090811
% of Active Formula: 0.5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 19, 2012
Final Report of Eyebrow Condition: Patient retained eyebrows
Before & After Photos: Yes
Comments: After four months of chemotherapy, chemo treatment was discontinued.
Patient
has reported no bodily hair loss whatsoever, (much to the surprise of the
medical staff).
2. 2% Active Black Cohosh Level Formula:
Participant #: 91
Gender: Female
DOB: 10-12-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Incomplete
Inventive Solution Used: Cell #3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report:
Final Report of Eyebrow Condition: Incomplete
Before & After Photos:
Comments: Patient out of study (will not be undergoing chemotherapy)
Participant #: 96
Gender: Female
DOB: 2-16-45
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Cytoxan & Docetaxel (every 3
weeks X
4 cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 0909811
% of Active Formula: 2%
CA 02794919 2012-11-13
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 16, 2012
Final Report of Eyebrow Condition: Retained eyebrows.
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient experienced approximately 25% loss of the
eyebrows.
Participant #: 97
Gender: Female
DOB: 2-13-68
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Carboplatin & Herceptin (every
3
weeks X 6 cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 21, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient experienced approximately 25% loss of the
eyebrows.
Participant #: 98
Gender: Female
DOB: 1-14-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell It 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: February 13, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient experienced approximately 25% loss of the
eyebrows.
Participant #: 103
Gender: Female
DOB: 5-18-76
Race: Caucasian
Medical Diagnosis: Hodgkin's Lymphoma
Description of Chemotherapy Regimen: Doxorubicin, Bleomycin, Vinblastine &
Dacarbazine (every 2 weeks)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
21
CA 02794919 2012-11-13
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 20, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which were 50% retained.
Participant #: 106
Gender: Female
DOB: 4-26-34
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: Incomplete (last follow-up on April 24, 2012)
Final Report of Eyebrow Condition: Incomplete result - (patient will be on
chemo thru end
of year)
Before & After Photos: Before photo taken
Comments: Patient out of study ¨ did not want to continue using the solution.
Participant #: 108
Gender: Female
DOB: 4-9-68
Race: Female
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 22, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient experienced approximately 20% loss of the
eyebrows.
Participant #: 109
Gender: Female
DOB: 3-5-75
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan (every 2 weeks X 4
cycles),
Taxol (every 3 weeks X 6 cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
22
CA 02794919 2012-11-13
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: August 8, 2012
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: Before photo taken
Comments: Patient out of study ¨ did not cooperate with proper application of
the solution
Participant #: 121
Gender: Female
DOB: 3-25-49
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles), followed by: Taxotere (every 2 weeks X 12 cycles)
Inventive Solution Used: Cell # 3B Formula #: 090911B Batch #: 090811
% of Active Formula: 2%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: Incomplete (last follow-up on August 8, 2012)
Final Report of Eyebrow Condition: Incomplete ¨ Retained eyebrows to date
(patient still
undergoing chemotherapy through October)
Before & After Photos: Before photo taken
Comments: Patient has reported full body hair loss with the exception of the
eyebrows,
which have been 50% retained. Patient is still undergoing chemotherapy and
will continue
using the solution.
3. 5% Active Black Cohosh Level Formula:
Participant #: 1
Gender: Female
DOB: 11-30-1963
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: July 28, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 2
Gender: Female
DOB: 6-25-64
Race: Caucasian
Medical Diagnosis: Breast Cancer
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CA 02794919 2012-11-13
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # I Formula: 042710 Batch: 042910
% of Active Formula: 5 %
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: Sept. 16, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 3
Gender: Female
DOB: 9-23-36
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 042910
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 29, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Confluents: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 4
Gender: Female
DOB: 6-14-49
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Taxol (every week) & Carboplatin (every 3
weeks)
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: July 28, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient reported that she retained her eyebrows during her months of
chemotherapy treatment. Patient passed away shortly after.
Participant #: 5
Gender: Female
DOB: 10-5-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere (every 3 weeks X 4 cycles),
Adriamycin
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CA 02794919 2012-11-13
& Cytoxan (every week for 3 weeks X 4 cycles (one week off)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 11, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 6
Gender: Female
DOB: 1-17-56
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Cytoxan & Adriamycin (every 3
weeks
X 4 cycles)
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: September 21, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 7
Gender: Female
DOB: 4-4-58
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan every 2 weeks for 8
weeks (4 cycles) followed by: Taxol every 2 weeks for 8 weeks (4 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 042910
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: September 21, 2010
Final Report of Eyebrow Condition: Patient experienced partial eyebrow loss
(approx.
50%)
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows
(approximately 50% loss). Patient reported that she did not fully adhere to
the proper
applications of the solution.
Participant #: 8
Gender: Female
DOB: 2-18-54
CA 02794919 2012-11-13
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: January 21, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient diagnosed with Metastatic Adenocarcinoma and will
continue
chemotherapy treatment of Adriamycin & Cytoxan. Patient passed away shortly
after.
Participant #: 10
Gender: Female
DOB: 7-4-45
Race: Caucasian
Medical Diagnosis: Bladder Cancer
Description of Chemotherapy Regimen: Taxol (every 3 weeks X 3 cycles),
followed by:
Carboplatin (every 3 weeks X 3 cycles) and Gemzar
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: September 21, 2010
Final Report of Eyebrow Condition: Patient experienced partial eyebrow loss
(approximately 50%)
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of
eyebrows
(approximately 50% loss). Patient reported that she did not fully adhere to
the proper
applications of the solution.
Participant #: 11
Gender: Female
DOB: 3-12-61
Race: African American
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxol (4 treatments total)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 042910
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: October 11, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
26
CA 02794919 2012-11-13
Participant #: 12
Gender: Female
DOB: 12-4-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: December 15, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 13
Gender: Female
DOB: 6-23-69
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 042910
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: November 4, 2010
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient retained eyebrows. Experienced partial loss of other bodily
hair.
Participant #: 14
Gender: Male
DOB: 12-15-43
Race: Caucasian
Medical Diagnosis: Bladder Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every 3 weeks X 8
cycles)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 042710
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: January 12, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient retained eyebrows
Participant #: 15
Gender: Female
DOB: 7-7-55
Race: Caucasian
27
CA 02794919 2012-11-13
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Incomplete
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Incomplete
Date of Final Report: August 5, 2012
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient out of study ¨ Experienced itching
Participant #: 16
Gender: Female
DOB: 5-17-49
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Gemzar
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 042910
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Incomplete ¨ Poor communication
Date of Final Report: September 27, 2010
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Failed to provide final photo
Comments: Incomplete Result
Participant #: 17
Gender: Female
DOB: 5-19-48
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Carboplatin & Taxol (every 4 weeks X 6
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 070610B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: January 12, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient retained eyebrows
Participant #: 19
Gender: Female
DOB: 3-13-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 3 weeks X 4
cycles), followed by: Taxotere ( 4 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
28
CA 02794919 2012-11-13
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 18, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 20
Gender: Female
DOB: 1-1-62
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Carboplatin & Taxotere (every 4 weeks X 8
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 070610B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: January 6, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 21
Gender: Female
DOB: 6-11-37
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Taxotere & Carboplatin (every week X 4
cycles),
followed by: Alimta & Carboplatin (every 3 weeks X 6 cycles)
Inventive Solution Used: Cell #2 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: May 17, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient retained eyebrows.
Participant #: 22
Gender: Female
DOB: 6-10-88
Race: Caucasian
Medical Diagnosis: Acute Lymphoblastic Leukemia
Description of Chemotherapy Regimen: Daunorubicin, Vincristine, Cytarabine
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
29
CA 02794919 2012-11-13
Follow-up Evaluations: Periodically
Date of Final Report: January 4, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient retained eyebrows during intense chemotherapy treatment from
August
25, 2010 ¨ January 4, 2011. Discontinued the solution due to severe skin rash
on entire body
from other medications.
Participant #: 23
Gender: Female
DOB: 1 1 -1 -3 I
Race: Caucasian
Medical Diagnosis: Tracheal Cancer
Description of Chemotherapy Regimen: Etoposide VP-16 & Carboplatin (3 days a
week,
every 2 weeks X 4 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: January 20, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient retained eyebrows
Participant #: 24
Gender: Female
DOB: 10-3-36
Race: Caucasian
Medical Diagnosis: Lymphoma
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Vincristine (every
3
weeks X 6 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 8, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 25
Gender: Female
DOB: 1-28-81
Race: Caucasian
Medical Diagnosis: Alopecia Areata
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 043010 Batch #: 070610B
CA 02794919 2012-11-13
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 29, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken
Comments: Patient has retained eyebrows despite almost full body hair loss
elsewhere.
Participant #: 26
Gender: Female
DOB: 12-2-46
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Incomplete
Date of Final Report: November 22, 2010
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: Before photo taken
Comments: Patient out of study ¨ Did not feel comfortable with it.
Participant #: 27
Gender: Female
DOB: 2-14-50
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Abraxane (3 weeks on, 1 week off)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Poor communication - Incomplete
Date of Final Report: March 22, 2011
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: Before photo taken
Comments: Incomplete result. Patient did not cooperate.
Participant #: 28
Gender: Female
DOB: 2-19-51
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxol, Carboplatin & Herceptin (every 3
weeks X
6 cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 043010
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: January 24, 2011
Final Report of Eyebrow Condition: Retained eyebrows
31
CA 02794919 2012-11-13
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 29
Gender: Female
DOB: 11-10-48
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Herceptin (every week X 12 weeks),
Taxotere &
Carboplatin (every 3 weeks X 12 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: January 20, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient passed away shortly after.
Participant #: 30
Gender: Female
DOB: 4-5-63
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin (discontinued after 1
treatment),
Docetaxel & Cytoxan (every 3 weeks X 4 cycles)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 070610A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 30, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Pt. experienced full body hair loss with the exception of the
eyebrows, which
were retained.
Participant #: 31
Gender: Female
DOB: 7-12-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: December 2, 2010
Final Report of Eyebrow Condition: Retained eyebrows
32
CA 02794919 2012-11-13
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 32
Gender: Female
DOB: 11-30-92
Race: Caucasian
Medical Diagnosis: Alopecia Areata
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report:
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has been using the solution for 6 months and reported that
she has
retained 75% of her eyebrows despite full body hair loss elsewhere. Patient is
continuing to
use the solution.
Participant #: 33
Gender: Female
DOB: 7-25-43
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Carboplatin & Taxol (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: April 8, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 34
Gender: Female
DOB: 8-25-59
Race: Caucasian
Medical Diagnosis: Breast Cancer (Triple Negative, Stage 2A)
Description of Chemotherapy Regimen: Adriamycin & Cytoxan, Taxol (every week X
11
weeks)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: April 8, 2011
33
CA 02794919 2012-11-13
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 35
Gender: Female
DOB: 4-29-54
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles) Taxotere (every 3 weeks X 4 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 5, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 36
Gender: Female
DOB: 9-18-48
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Carboplatin & Etoposide
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: April II, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 37
Gender: Female
DOB:
Race: Caucasian
Medical Diagnosis: Alopecia Areata
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 29, 2012
34
CA 02794919 2012-11-13
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Before photo taken
Comments: Patient discontinued application of the solution when she exhausted
her supply.
Participant #: 38
Gender: Female
DOB: 10-19-91
Race: Caucasian
Medical Diagnosis: Hodgkin's Lymphoma
Description of Chemotherapy Regimen: Adriamycin, Bleomycin, Vinblastine &
Dacarbazine (every 2 weeks for 6 months)
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: July 16, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient retained eyebrows
Participant #: 39
Gender: Female
DOB: 4-17-44
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Cisplatin & Taxol (every 3 weeks X 5
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 2, 2011
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of her
eyebrows
throughout her chemotherapy treatment. Patient discontinued application of the
solution
immediately following her final chemo treatment and reported eyebrow loss
shortly after.
Participant #: 40
Gender: Female
DOB: 9-25-85
Race: Egyptian
Medical Diagnosis: Hodgkin's Lymphoma
Description of Chemotherapy Regimen: Adriamycin, Bleomycin, Vinblastine &
Dacarbazine (every 2 weeks for 3 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report: 5-29-12
CA 02794919 2012-11-13
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: Before photo taken
Comments: Patient out of study. Patient returned to her residence in Egypt.
Participant #: 41
Gender: Female
DOB: 6-22-51
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Carboplatin & Irinotecan (every 3 weeks X
2
cycles). On 8-4-11 started Taxotere & Navelbine (3 weeks on, one week off -
indefinitely)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: January 5, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of her
eyebrows,
which were retained.
Participant #: 42
Gender: Female
DOB: 6-15-63
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Taxol (every week X
8
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: February 17, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 43
Gender: Female
DOB: 8-16-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Carboplatin, Taxol & Gemzar
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 100110A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report: June 28, 2011
Final Report of Eyebrow Condition: Unknown
36
CA 02794919 2012-11-13
Before & After Photos: Before photo taken
Comments: Incomplete result ¨ patient did not cooperate
Participant #: 44
Gender: Female
DOB: Incomplete
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Incomplete
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 100110B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Incomplete
Date of Final Report: April 1, 2011
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient reported that she did not adhere to the proper applications
of the
solution.
Participant #: 45
Gender: Female
DOB: 2-20-54
Race: Caucasian
Medical Diagnosis: Non-Hodgkin's Lymphoma
Description of Chemotherapy Regimen: Cytoxan, Vincristine, Adriamycin &
Rituxan
(every 3 weeks for 6 months)
Inventive Solution Used: Cell #1 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 28, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 46
Gender: Female
DOB: 9-26-41
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: June 28, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
37
CA 02794919 2012-11-13
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 47
Gender: Female
DOB: 7-26-51
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Incomplete
Date of Final Report: May 25, 2011
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient was hospitalized and discontinued use of solution.
Incomplete result.
Participant #: 48
Gender: Female
DOB: 9-26-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Taxol (every 2 weeks X 4
cycles),
Taxol (every week X 12 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 28, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 49
Gender: Female
DOB: 9-22-64
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: May 27, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
38
CA 02794919 2012-11-13
Participant #: 50
Gender: Female
DOB: 12-1-65
Race: Caucasian
Medical Diagnosis: Alopecia Areata
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report:
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken
Comments: Out of study ¨ Chose not to participate
Participant #: 51
Gender: Female
DOB: 1-16-55
Race: Caucasian
Medical Diagnosis: Pancreatic Cancer
Description of Chemotherapy Regimen: 5-FU/Leucovorin, Irinotercan &
Oxaliplatin
(every 2 weeks X 12 cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: July 1, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient has recently passed away.
Participant #: 52
Gender: Female
DOB: 2-5-65
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Carboplatin (every 3 weeks X 5
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report: May 25, 2011
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient discontinued application of the solution. Incomplete result.
39
CA 02794919 2012-11-13
Participant #: 53
Gender: Female
DOB: 10-7-29
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every week X 3
cycles)
Inventive Solution Used: Cell #2 Formual #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: June 1, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient retained eyebrows.
Participant #: 54
Gender: Female
DOB: 3-13-30
Race: Caucasian
Medical Diagnosis: Lymphoma
Description of Chemotherapy Regimen: Cytoxan, Adriamycin, Rituxan &
Vincristine
(every 3 weeks X 8 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 28, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 55
Gender: Female
DOB: 9-30-47
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan& Taxol (every 3 weeks
for
6 months), followed by: Herceptin & Taxol for 3 months.
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: August 22, 2011
Final Report of Eyebrow Condition: Delayed loss of eyebrows
Before & After Photos: Before photo taken
Comments: Patient underwent very aggressive chemotherapy treatment and lost
all body
hair including fingernails and toenails. Patient reported delayed loss of
eyebrows.
CA 02794919 2012-11-13
Participant #: 56
Gender: Female
DOB: 1-9-47
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Ellence & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 24, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 58
Gender: Female
DOB: 8-6-63
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 25, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 59
Gender: Female
DOB: 4-18-52
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 12, 2011
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 60
41
CA 02794919 2012-11-13
Gender: Female
DOB: 3-5-71
Race: Caucasian
Medical Diagnosis: Lymphoma
Description of Chemotherapy Regimen: Cytoxan, Adriamycin, Rituxan &
Vincristine
(every 3 weeks X 6 cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 11, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 61
Gender: Female
DOB: 4-24-43
Race: Hispanic
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: August 11, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 62
Gender: Female
DOB: 5-28-47
Race: Caucasian
Medical Diagnosis: Lung Cancer
Description of Chemotherapy Regimen: Taxotere (every 3 weeks, one week off,
for 3
months)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: November 11, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient retained eyebrows
Participant #: 63
42
CA 02794919 2012-11-13
Gender: Female
DOB: 7-10-35
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell # 2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: July 28, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 64
Gender: Female
DOB: 8-21-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxol, Cytoxan & Herceptin (every 3 weeks
X 4
cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 1, 2011
Final Report of Eyebrow Condition:
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 66
Gender: Female
DOB: 1-14-53
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: November 1, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 67
43
CA 02794919 2012-11-13
Gender: Female
DOB: 6-1-62
Race: Caucasian
Medical Diagnosis: Multiple Myeloma
Description of Chemotherapy Regimen: Velcade (twice a week for 2 weeks, 2
weeks off
for 3 months), Cytoxan (one injection in June), Melphalan (one injection in
July)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: September 23, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 68
Gender: Female
DOB: 3-23-45
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Gemzar (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: November 13, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 69
Gender: Female
DOB: 4-9-47
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cisplatin. Taxol & Herceptin (12 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: November 1, 2011
Final Report of Eyebrow Condition: Patient lost eyebrows
Before & After Photos: Yes
Comments: Patient reported that she did not adhere to the proper application
of the solution.
Participant #: 70
Gender: Female
DOB: 11-2-63
44
CA 02794919 2012-11-13
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: October 22, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 71
Gender: Female
DOB: 12-26-68
Race: Caucasian
Medical Diagnosis: Non-Hodgkin's Lymphoma
Description of Chemotherapy Regimen: Vincristine (one treatment), Cytoxan &
Adriamycin (every 3 weeks X 6 cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: September 30, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 73
Gender: Female
DOB: 11-20-56
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: September 24, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 74
Gender: Female
DOB: 11-16-?
Race: Caucasian
CA 02794919 2012-11-13
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Taxotere (every 3
weeks
X 6 cycles)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: October 21, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 75
Gender: Female
DOB: 8-6-41
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Incomplete
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Poor communication - Incomplete
Date of Final Report:
Final Report of Eyebrow Condition:
Before & After Photos:
Comments: Patient out of study. Incomplete result.
Participant #: 76
Gender: Female
DOB: 7-16-63
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Vincristine, Adriamycin, Cytoxan & Mesna
(every 3 weeks)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 1, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 77
Gender: Female
DOB: 8-7-67
Race: Caucasian
Medical Diagnosis: Breast Cancer
46
CA 02794919 2012-11-13
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: October 21, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 78
Gender: Female
DOB: 1-16-59
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Taxol & Carboplatin (every 4 weeks X 6
cycles)
Inventive Solution Used: Cell #1 Formula #: 043010 Batch #: 122710B
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 21, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient experienced partial eyebrow loss (approximately 50%).
Patient reported
she did not fully adhere to the proper application of the solution.
Participant #: 79
Gender: Female
DOB: 4-20-51
Race: Caucasian
Medical Diagnosis: Lymphoma
Description of Chemotherapy Regimen: CHOP-R
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Incomplete
Date of Final Report:
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient changed her mind and decided not to be a study participant.
Participant #: 80
Gender: Female
DOB: 4-2-62
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Taxol (every 2
weeks X
4 cycles)
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 052411
47
CA 02794919 2012-11-13
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: November 17, 2011
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 81
Gender: Female
DOB: 2-16-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 3 weeks X 4
cycles), followed by: Taxotere (3 weeks on, one week off, for 12 weeks)
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 7, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 82
Gender: Female
DOB: 5-17-69
Race: Caucasian
Medical Diagnosis: Endometrial/Ovarian Cancer
Description of Chemotherapy Regimen: Taxotere & Carboplatin (every 3 weeks X 6
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: January 13, 2012
Final Report of Eyebrow Condition: Patient experienced partial eyebrow loss
(approximately 50%)
Before & After Photos: Yes
Comments: Patient experienced partial eyebrow loss (approximately 50%).
Patient reported
that she did not fully adhere to the proper application of the solution.
Participant #: 83
Gender: Female
DOB: 9-11-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
48
CA 02794919 2012-11-13
Inventive Solution Used: Cell #1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: January 5, 2012
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 84
Gender: Female
DOB: 7-22-53
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Carboplatin & Herceptin (every
3
weeks X 6 cycles)
Inventive Solution Used: Cell # 2 Formula #: 04310 Batch #: 052411
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Periodically
Date of Final Report: March 14, 2012
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 85
Gender: Female
DOB: 11-24-61
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: March 7, 2011
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Before photo taken (failed to provide final photo)
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained. Patient has recently passed away.
Participant #: 86
Gender: Female
DOB: 3-3-59
Race: Caucasian
Medical Diagnosis: Ovarian Cancer
Description of Chemotherapy Regimen: Carboplatin & Gemzar & Avastin
(indefinitely)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 052411
49
CA 02794919 2012-11-13
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: May 28, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken
Comments: Patient has been on chemotherapy since August 2011, and has retained
her
eyebrows despite almost full body hair loss elsewhere. Patient is continuing
to use the
eyebrow solution.
Participant #: 87
Gender: Female
DOB:
Race:
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell #2 Formula #: 043010 Batch #: 052411
% of Active Formula: 5%
PH: 8
Follow-up Evaluations: Poor communication ¨ Incomplete result
Date of Final Report:
Final Report of Eyebrow Condition: Incomplete
Before & After Photos: Before photo taken
Comments: Patient out of study ¨ Incomplete result
Participant #: 88
Gender: Female
DOB: 1 1 -17-47
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: October 3, 2011
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Yes
Comments: Patient experienced full body hair loss with the exception of the
eyebrows,
which were retained.
Participant #: 89
Gender: Female
DOB: 8-31-57
Race: Caucasian
Medical Diagnosis: Metastatic Lung Cancer
Description of Chemotherapy Regimen: Cisplatin & Etopocide
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 052411
% of Active Formula: 5%
PH: 5-6
CA 02794919 2012-11-13
Follow-up Evaluations: Periodically
Date of Final Report: February 9, 2012
Final report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Before photo taken
Comments: Patient reported that she retained her eyebrows during her 5 months
of
chemotherapy treatment. Patient recently passed away.
Participant #: 113
Gender: Female
DOB: 11-18-64
Race: Caucasian
Medical Diagnosis: Alopecia Areata
Description of Chemotherapy Regimen:
Inventive Solution Used: Cell # 1 Formula #: 042710 Batch #: 122710A
% of Active Formula: 5%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: Incomplete (last follow-up on 5-29-12)
Final Report of Eyebrow Condition: Incomplete ¨ Patient still using solution.
Before & After Photos: Before photo taken
Comments: Patient has reported noticeable improvement in eyebrow density since
using the
solution.
4. 10% Active Black Cohosh Level Formula:
Participant #: 101
Gender: Female
DOB: 5-23-70
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan (every 2 weeks X 4
cycles),
Taxol (every week X 12 weeks), Herceptin
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 8, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which were retained.
Participant #: 102
Gender: Female
DOB: 5-8-62
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles), Taxol (every week X 12 cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
51
CA 02794919 2012-11-13
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 3, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Conunents: Patient has experienced full body hair loss with the exception of
the eyebrows,
which were 50% retained.
Participant #: 110
Gender: Female
DOB: 4-11-70
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles), Taxol & Herceptin (every week for 13 weeks)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: August 8, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 111
Gender: Female
DOB: 2-25-57
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxol (every week X 12 cycles), Cytoxan,
5 FU,
& Epirubicin (2 cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: August 12, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Conunents: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 115
Gender: Female
DOB: 3-16-52
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere, Adriamycin & Cytoxan (every 3
weeks
52
CA 02794919 2012-11-13
X 6 cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 18,2012
Final Report of Eyebrow Condition: Retained Eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 116
Gender: Female
DOB: 11-30-50
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Taxotere & Cytoxan (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 6, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 117
Gender: Female
DOB: 12-30-65
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan 8z Neosar (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: July 18, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which were retained.
Participant #: 118
Gender: Female
DOB: 6-4-50
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Cytoxan & Taxotere (every 3 weeks X 4
cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
53
CA 02794919 2012-11-13
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 11, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 119
Gender: Female
DOB: 8-13-57
Race: Asian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin, Cytoxan & Herceptin (every 2
weeks X 4 cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically
Date of Final Report: June 18, 2012
Final Report of Eyebrow Condition: Retained eyebrows
Before & After Photos: Yes
Comments: Patient has experienced full body hair loss with the exception of
the eyebrows,
which have been retained.
Participant #: 120
Gender: Female
DOB: 7-19-55
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Adriamycin & Cytoxan (every 2 weeks X 4
cycles), followed by: Taxotere (every 3 weeks X 4 cycles)
Inventive Solution Used: Cell # 3A Formula #: 090911A Batch #: 090811
% of Active Formula: 10%
PH: 5-6
Follow-up Evaluations: Periodically (last follow-up on August 1, 2012)
Date of Final Report: Incomplete ¨ Patient still undergoing chemo thru October
Final Report of Eyebrow Condition: Incomplete (Retained eyebrows to date)
Before & After Photos: Before photo taken
Comments: Patient has reported full body hair loss with the exception of the
eyebrows,
which have been retained. Patient is still undergoing chemotherapy and will
continue using
the solution.
Incomplete Results:
Participant #: 9
Gender: Female
DOB: 7-9-64
54
CA 02794919 2012-11-13
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Patient elected not to undergo
chemotherapy (had
surgery)
Inventive Solution Used:
% of Active Formula:
PH:
Follow-up Evaluations:
Date of Final Report:
Final Report of Eyebrow Condition:
Before & After Photos:
Comments: Patient out of study
Participant #: 18
Gender: Male
DOB:
Race:
Medical Diagnosis:
Description of Chemotherapy Regimen:
Inventive Solution Used:
% of Active Formula:
PH:
Follow-up Evaluations:
Date of Final Report:
Final Report of Eyebrow Condition:
Before & After Photos:
Comments: Patient dropped out before he utilized the solution.
Participant #: 57
Gender: Female
DOB: 9-28-61
Race: Caucasian
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen:
Inventive Solution Used:
% of Active Formula:
PH:
Follow-up Evaluations:
Date of Final Report:
Final Report of Eyebrow Condition:
Before & After Photos: Before photo taken
Comments: Patient out of study (did not undergo chemotherapy treatment)
Participant #: 65
Gender: Female
DOB: Incomplete
Race:
Medical Diagnosis: Breast Cancer
Description of Chemotherapy Regimen: Incomplete
Inventive Solution Used:
CA 02794919 2012-11-13
% of Active Formula:
PH:
Follow-up Evaluations: Incomplete
Date of Final Report:
Final Report of Eyebrow Condition: Incomplete result
Before & After Photos: No
Comments: Patient dropped out of the study before she utilized the solution.
Participant #: 72
Gender:
DOB:
Race:
Medical Diagnosis:
Description of Chemotherapy Regimen:
Inventive Solution Used:
% of Active Formula:
PH:
Follow-up Evaluations:
Date of Final Report:
Final Report of Eyebrow Condition:
Before & After Photos:
Comments: There is no participant #72 ¨ Recording error.
[0079] As shown in this Example, virtually all participants undergoing
chemotherapy who used a formulation that contained 0.5 percent by weight black
cohosh
extract lost all of their body hair, including their eyebrows.
[0080] Participants undergoing chemotherapy who used a formulation that
contained
2 percent by weight black cohosh extract retained about 75 percent of their
eyebrows (a 25
percent loss), despite experiencing full body hair loss elsewhere.
[00811 Virtually all participants undergoing chemotherapy who used a
formulation
that contained 5 percent by weight black cohosh extract have all retained
their eyebrows,
despite experiencing full body hair loss elsewhere.
[0082] All participants undergoing chemotherapy who used a formulation that
contained 10 percent by weight black cohosh extract have all retained their
eyebrows, despite
experiencing full body hair loss elsewhere.
[0083] As the above examples demonstrate, compositions and methods of the
invention are effective in reducing and preventing hair loss, particularly the
loss of eyebrows,
in patients undergoing chemotherapy. All subjects underwent a chemotherapy
regimen that
normally is associated with complete body hair loss, yet all retained some or
all of their
eyebrows. Subjects who complied fully with the application protocol fully
retained their
eyebrows despite experiencing complete body hair loss everywhere else.
56
