Note: Descriptions are shown in the official language in which they were submitted.
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SKIN TREATMENT METHOD UTILIZING AN ALPHA-HYDROXY ACID
COMPOSITION AND AN APPLICATOR PAD
The present invention relates to topical compositions
for producing healthy, youthful, attractive, natural,
looking human skin, and for addressing certain problem skin
conditions, including aging skin, dry skin, photo aged
skin, i.e., sun damaged skin, hyperpigmentation [brown and
black blotchesJ or darkly pigmented skin [e.g. natural skin
pigmentation of black persons], acne, eczema, thin skin,
which occurs commonly in Caucasian women between the ages
of 25 and 40, where skin thickness is reduced, sensitive
skin and composite dry-oily skin also known as T-zone oily
skin.
BACKGROUND OF THE INVENTION
It is known ttiat the epidermal, or outer layers of
human skin can be caused to peel by applying alpha hydroxy
acid ("AHA") containing preparations, such as glycolic
acid, in order to remove dead skin and to wound underlying
living skin tissue. The beneficial result of such skin
peeling is that when underlying layers of skin are exposed,
the underlying skin is relatively free of age lines,
superficial wrinkles, acne scarring, scaliness, pigment
spots, aging spots, acne lesions, and, with an appropriate
topical composition, without the same relative degree of
hyperpigmentation as compared to the same skin before a
topical peeling composition was applied.
Removing old, dead surface skin cells exposes younger
underlying skin tissue, which looks more youthful in part
because it is smoother and reflects light more readily,
thus rendering a"healthy glow" appearance. Removal of the
buildup of dead skin cells is critical to producing
younger-looking skin because the dead cell buildup is
partly responsible for the rough, dry look associated with
superficial fine lines, crow's feet, wrinkles and the like.
Skin exfoliation involves removing the surface layer
of dead skin cells. To accomplish this, the surface dead
cells must be penetrated and either removed by manual
met}iods employing mechanical activity or by chemical
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methods in which surface dead cells must be penetrated by
the exfoliating agents.
The present invention also uses AHAs, and preferably
and particularly the AHA glycolic acid, as an agent to
loosen the bonds between dead skin cells and underlying
living tissue and stimulate the living skin tissue to form
new collagen and to metabolically remove and reorganize
dead cells and detritus.
In contrast, products which are solely peeling agents
and/or exfoliants, such as salicylic acid, even when
provided in an applicator pad, involve only contact with
and removal of all or a portion of the surface dead skin,
without affecting the underlying living skin tissue.
Exfoliation of the skin is a more gentle skin
treatment process than chemical peeling, since exfoliation,
unlike peeling, removes only dead skin cells from the skin
surface and does not wound living cells. Peeling, in
contrast, wounds living skin cells and stimulates both
healing and the production of collagen and other cellular
materials.
DISCUSSION OF THE PRIOR ART
Various attempts have been made to utilize alpha-
hydroxy acids, such as glycolic acid, in skin care
products, as noted in U.S. patent Numbers 3,879,537,
3,920,835, 3,984,566, 3,988,470, 4,021,572, 4,105,783,
4,197,316, 4,234,599, 4,246,261, 4,363,815, 4,380,549, and
4,363,815 of Van Scott and Yu, as well as U.S. Patent
Numbers 4,294,852 of Wildnauer.
However, such patents do not disclose the use of an
alpha-hydroxy acid, such as glycolic acid, impregnated into
a pad, such as a medicated cleansing pad or a cosmetic
applicator pad for frequent periodic use and the
application thereof.
Cosmetic applicator pads and/or medicated cleansing
pads fabricated for very specific material compositions
have been described in use with salicylic acid and alcohol,
as noted in U.S. patent no. 4,891,228 of Thaman.
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However, alpha hydroxy acids, such as glycolic acid
are much better at treating skin conditions, because of
their activity in relation to the removal of dead skin
layers and moisturizing and treating live skin. Moreover,
glycolic acid is the preferred alpha hydroxy acid because
it penetrates the dermal layers better by virtue of its
relatively smaller molecular size than other alpha hydroxy
acids having larger molecular sizes, such as lactic acid.
Alternatively, glycolic acid acts at peeling and/or
exfoliating skin when used synergistically in combination
with relatively low concentrations of acetone.
Other related preparations for skin treatment include
U.S. patent Nos. 4,035,513 of Kumano, 4,124,720 of
Wenmaekers, 4,195,077 of Marsh, 4,287,214 of Van Scott and
Yu, 4,608,370 of Aronsohn, 4,695,452 of Gannis, 4,824,865
of Bowser, 4,830,854 of Copelan, 4,931,591 of Buhlmayer,
5,110,603 of Rau and 5,164,413 of Willis.
In connection with the alternate topical use of
acetone, the following prior art is relevant: U.S patent
5,133,967 to Smith for a skin toning composition which
proposes the use of glycol ether instead of acetone and
alcohol to degrease and de-fat the skin. U.S. patent
5,154,174 describes the use of acetone as a skin drying
agent in preparation for attachment of transdermal
electrodes to the skin. U.S. patents 5,145,858 and
5,140,047, 5,134,150 and 4,847,270 for bactericides teach
acetone for drying the skin, in conjunction with
moisturizers, such as glycerol or castor oil. U.S.
5,091,379 describes acetone in an anti-inflammatory
composition. U.S. patent 5,049,381 and 4,980,378 disclose
the use of acetone for penetration of skin tanning
coloration compositions or products. Moreover, the New
Jersey Department of Health "Hazardous Substances Fact
Sheet: Acetone" Cas. No. 67-64-1, DOT No. UN 1090 Feb.
1989 warns that excessive use of acetone causes skin
dryness.
However, none of these prior art documents teach the
use of acetone as a peeling agent, as opposed to a drying
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agent. However, such use can be supported, since in high
concentrations acetone has been shown to cause blistering
or excessive peeling by abnormal erosion of skin layers, as
noted in Kechijian, "Nail Polish Removers: Are They
Harmful?", Dept. of Dermatology, N.Y.U. School of
Medicine, New York, N.Y., published by W.B. Saunders
Company, 1991.
In the prior art, chemical peeling has been done in
dermatologists' aestheticians' and cosmetologists' offices,
and has been accomplished over a period of minutes or
hours, generally in a single visit. The problems with such
chemical peels include use of relatively high
concentrations of such peeling agents as AHAs, including
the use of glycolic acid, trichloroacetic acid and phenol
compounded into a suitable vehicle, with concentrations
being typically from 30% up to as much as 90% in the prior
art. Traditional chemical peeling, then, has been swift,
harsh, often painful, and, due to the harshness has been
undesirable.
In the course of chemical peeling surface debris,
including dead skin cells, are removed partly through
mechanical abrasive action of applying and removing the
chemical peel agents and partly through the activity of the
chemical peeling agents which, among other effects, break
bonds by which dead skin cells adhere to living skin cells.
In the prior art, peeling agents have been applied and then
neutralized and/or physically removed from the skin after
the desired treatment time period has elapsed.
Chemical peeling can be done in varying degrees of
depth, typically called light, or superficial, and medium
and deep peels. A light peel is generally one which is
comparatively superficial in effect and a deep chemical
peel is one in which peeling agents are used to produce a
moderate to severe wound to the skin. However, a deep peel
achieves a much more profound effect, and does so quickly,
in minutes or hours. As a result, pain and inflammation
usually result. Deep peeling usually produces redness
lasting several days, a large and deep separation of dead
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skin, and the exposure of what, before the deep peel, was
relatively deep living skin tissue.
The results of deep peeling are not equivalent to the
results of light or superficial peels or exfoliation.
5 Whereas deep peeling potentially produces undesirable
redness, itching, pain, inflammation and unwanted or
excessive peeling of living tissue which may last days
after the deep peel treatment, light peels produce few or
no such undesirable side effects. The cosmetic results of
deep peeling are more dramatic and more visible than the
results available with light and medium peeling and
exfoliation.
But where excessive or prolonged and unwanted peeling
occurs in the aftermath of a deep peel treatment, it is
difficult or impossible to apply cosmetics to the affected
skin due to the continued peeling and due to the pain,
itching, inflammation and redness of the skin.
However, it should be noted that prior art peeling is
accomplished by the application of high-concentration
peeling agents either in a single treatment session, or, at
most, over a period of repetitive treatments over several
days or weeks in a professional setting, i.e., the office
of a dermatologist, an aesthetician or a cosmetologist.
As a general matter, skin to be peeled has been first
degreased in the prior art. In some prior art, there has
also been another intermediate preparatory step in which
various agents are applied to the skin in order to more
effectively degrease it. After the skin is prepared by
degreasing, the peeling agents have been applied in the
prior art. The peeling agents are then neutralized and/or
removed after a non-standardized duration. Finally,
affected skin has been topically treated with a moisturizer
or other after-care preparation.
Moreover, even where mere exfoliants are used, such as
salicylic acid in combination with alcohol, as disclosed in
Thaman, the results are not as beneficial as in the present
invention, where alpha hydroxy acids are used.
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The AHA's of the present invention serve not only as
agents for skin peeling and/or exfoliating, but also as
skin moisturizers, by virtue of their humectant qualities.
In addition, the prior art does not provide for
standardization of peeling or exfoliation. For example, a
professional practitioner, i.e., a dermatologist,
aesthetician or cosmetologist applies skin peeling agents
which the practitioner has purchased containing individual
ingredients such as glycolic acid. Prior art practitioners
have used a variety of application methods, with no
standardized quantity of agents being applied. Therefore
there is no standardization of any part of the chemical
peeling process in any of the prior art. By so doing,
there can be no standardization of peeling materials or
their concentrations among skin treatment practitioners.
In addition to the widely variable ingredients and
concentrations of skin peel agents, there has been no
standardization in the preparation of skin before
application of the peeling agents, no standardization of
the duration of skin contact with the peeling agents, no
standardization of the degree of abrasiveness employed in
the course of treatment, and no standardization of post-
treatment for affected skin. The aforementioned lack of
standardization has produced unpredictable results in the
art of skin peeling/exfoliation.
As a general matter,.skin to be peeled has been first
cleansed in the prior art. In some prior art, there has
also been another intermediate preparatory step in which
various agents are applied to the skin in order to more
effectively degrease it. After the skin is prepared by
cleansing and/or degreasing, the peeling agents have been
applied in the prior art. The peeling agents are then
neutralized and/or removed after a non-standardized
duration. Finally, affected skin has been topically
treated with a moisturizer or other after-care preparation.
Additional disadvantages of the prior art have been
the nonstandardization in the additional critical areas of
variability in the effectiveness and depth of skin
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penetration achieved by the skin peeling agents, due to
uncontrolled variability in preparatory degreasing;
variability in types and concentrations of peeling agents
due to the presence or absence of solvents such as alcohol
mixed with and applied w.ith the peeling agents themselves;
variability in the duration of peeling agent contact with
the skin; variability in degree of abrasiveness employed in
the course of skin peeling or exfoliation; and, variability
in the materials, manner and frequency of post-peel skin
treatment. There is also no way for a professional to know
how much of the peeling agent to apply as the dose has not
been premeasured or standardized.
FEATURES OF THE INVENTION
It is a feature of one embodiment of the present
invention to provide a skin peeling/exfoliating system for
at-home use.
It is another feature of preferred embodiments of the
present invention to provide a skin peeling/exfoliating
system which eliminates the necessity for expensive
inconvenient professional supervision for peeling or
exfoliation skin treatment. It is a further feature of the present invention
to
provide, in preferred embodiments, a skin
peeling/exfoliating system involving frequented repeated
application of peeling/exfoliating agents over a selected
period of days to obtain predictable, reliable results.
It is another feature of a preferred embodiment of the
present invention to provide a skin peeling/exfoliating
treatment system treatment employing a skin peeling/
exfoliating agent which comprises a unique combination of
skin peeling/exfoliating materials.
It is another feature of the present invention, in
preferred embodiments, to provide a skin peeling/exfoliating
treatment system employing a delivery system using cosmetic
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applicator pads and/or medicated applicator pads, preferably
having a selected degree of abrasiveness.
It is another feature of preferred forms of the present
invention to provide a skin peeling/exfoliating treatment
system employing a delivery system using cosmetic applicator
pads and/or medicated applicator pads presaturated with a
desired quantity of a skin peeling exfoliating agent.
It is another feature of the present invention to
provide, in preferred embodiments, a skin peeling/
exfoliating treatment system employing a'plurality of
applicator pads saturated with materials for frequent
periodic peeling/exfoliating steps which are also
moisturizing steps.
It is another feature of a preferred embodiment of the
present invention to provide a skin peeling/exfoliating
treatment system which provides a method of treating and
improving the appearance of skin subject to a variety of
conditions, including aging skin, hyperpigmentation, acne,
sensitive skin, dry-oily skin and the like.
It is another feature of a preferred embodiment of the
present invention to provide a skin peeling/exfoliating
treatment system wherein the skin peeling/exfoliating agent
is left on the skin, and which, by the virtue of leaving it
on, becomes a skin moisturizer.
It is yet another feature of a preferred embodiment of
the present invention to provide a skin degreasing, skin
peeling and/or exfoliating treatment system with a cosmetic
and/or medicated applicator pad which provides an agent
which is left on the skin, and which, by the virtue of
leaving it on, serves as both a skin moisturizer and a
treatment for the skin.
SUMMARY OF THE INVENTION
In addressing the problems found in the prior art, the
present invention provides a method of treatment for skin
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conditions, including an abrasive and absorbent applicator
pad, preferably in a kit or at home use, for delivery of a
composition for effective skin peeling and exfoliation as
well as moisturization which is applied in concentrations of
the active skin peeling ingredients far lower than that
routinely used in dermatologists' offices. In addition, if
used at frequent periodic intervals, such as daily, over a
period of a few weeks, the use of the composition,
preferably applied with an applicator pad, provides a light
at-home chemical skin peel. The composition of the present
invention, preferably as delivered by the pad, provides an
effective composition and method in that the controlled
concentration of at least one peeling agent permits the
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peeling agent to be left on the skin of the user for a
relatively extensive duration.
It is to be noted that the peeling agents of the
various embodiments of the present invention may be
treatment compositions containing a single alpha hydroxy
acid (AHA) or a combination of the AHAs as set forth in
detail hereinafter.
Frequent periodic treatment of the skin and long-
duration skin contact with the peeling agents effects the
slow peeling results which are an object of the present
invention. In addition, the efficacy of the present
invention substantially avoids irritating or wounding the
skin in a manner perceptible to the user is a further novel
advantage.
Because the peeling/exfoliation treatment composition
of the present invention is thus effective without skin
irritation or wounding which is perceptible, the
composition of the present invention may be, and is
intended to be left upon the skin of the user without the
neutralization or removal required in the prior art. Thus,
the present invention is designed to be used at least once
daily over a period of weeks to produce the same or a
superior result compared to light or superficial chemical
peels alone.
The alternate embodiment of the present invention is
better than a cream containing AHAs and/or glycolic acid
because the acetone in the alternate embodiment of the
present invention acts as a further peeling agent in its
own right and further acts as an aggressive solvent to
strip the skin of oil and grease and thus allows the
exfoliating agents to penetrate deeper. An exfoliating
agent in a cream base treatment composition which fails to
employ acetone cannot penetrate as deeply and thus cannot
achieve the superior results of the present invention.
Thus, with the alternate acetone component of the
present invention, the exfoliating agents penetrate deeper
and are more effective in exfoliating the skin. The key
novel aspects is the present invention's ability to deliver
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the degreasing, exfoliating and moisturizing agents to the
appropriate layers of skin where degreasing, exfoliating
and moisturizing is to occur. ,
In contrast to the prior art which requires expensive
and potentially inconvenient professional treatment for
skin exfoliation, the present invention provides convenient
and inexpensive skin degreasing, exfoliating and
moisturizing at home, in a non-professional setting,
utilizing treatment compositions containing exfoliating
10 and/or degreasing or moisturizing agents applied only once
per day over a period lasting a minimum of five days. Other
differences between the present invention and the prior art
will be fully set forth herein.
In addressing the aforementioned features, the present
invention provides a composition, a method of treatment and
a treatment applicator pad for at-home skin exfoliating
and/or degreasing or moisturizing, which is gentle in that
the concentrations of the active skin exfoliating and/or
degreasing or moisturizing ingredients are far lower than
ttiat utilized in the professional offices of
dermatologists, cosmetologists and aestheticians.
The composition of the present invention is designed
to be used at least once daily over a period of weeks to
produce the same or a superior result compared to chemical
peels available in an intense, harsh dermatological
treatment lasting merely for a period of minutes or hours.
The present invention is better than prior art AHA
containing creams or lotions because the use of the
applicator pad debrides the skin, thereby providing better
penetration of the skin layers by the AHAs. Better
penetration, in turn, permits the slow peeling and/or
exfoliating which is the object of using the AHAs. The use
of at least one AIIA with the applicator pad of the present
invention provides a convenient, user-friendly product
intended for at least once daily use in a non-professional
setting, such as at the home of the user.
The pads themselves are effective in removing the dead
skin debris, dirt and oil in that the pad removes these
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materials. In addition, the applicator pad, which is
presaturated with the AHA material, leaves the low-
concentration AHA material on the skin while removing
unwanted debris, dirt and oil. The clearing of debris,
dirt and oil and simultaneous AfiA topical application
allows far greater AHA efficacy than if the AtiAs were
applied to dirty, unprepared skin. In addition, the pad
enables greater AHA efficacy than if the skin had been
simply cleansed prior to ttie application of the AIiAs.
Ttie pads themselves are commercially available
flexible, absorbant, sponge-like cosmetic applicator pads
whicti allow the presaturated AHAs to be expressed onto the
skin with mild manual pressure and which also provide
abrasion when drawn across the skin with mild to moderate
manual pressure.
Mildly abrasive cosmetic applicat-or pads are
commercially available under the name *SONTARA pads,
described as a non-woven/spun laced pad comprised of rayon
and polyester from KLEEN TEST PRODUCTS, P.O. Box 574
Milwaukee, WI. Moderately abrasive cosmetic applicator
pads, also available from KLEEN TEST PRODUCTS are described
as *NOVO pads.
Mildly abrasive and absorbant pads, e.g., SONTARA
pads, are used for AHA preparations which have a relatively
low-viscosity liquid or liquid-like pharmaceutical vehicle.
The moderately abrasive NOVO pads can be used with the same
relatively low-viscosity liquid or liquid-like
pharmaceutical vehicle, but the NOVO pads can also be used
with AFIA preparations with higher viscosities, such as
lotions, creams and lipid-based pharmaceutical vehicles.
Strongly abrasive pads, such as the BUFF PUFF pad can
also be presaturated with AlIAs in a pharmaceutical vehicle,
but strongly abrasive applicators are not preferred in the
present invention.
'I'he above-mentioned cosmetic applicator pads may also
be manufactured in a two-sided embodiment. One side has
relatively greater abrasiveness and the remaining side is
less abrasive. The more abrasive side of the pad is used
*Trade-mark
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to debride the skin, loosening and removing dead skin cells
and debris, while at the same time depositing a material
with which the pad has been presaturated. Such material is
typically, but not necessarily, the peeling and/or
exfoliating agent of the present invention. The pad,
presaturated with an alternate material, could be used to
apply a cleanser or a skin degreasing composition.
The two-sided pad's less abrasive side is used to
absorb dirt, skin oil and debris from the skin to be
treated. The user first applies the more abrasive side of
the two-sided pad by gently wiping the skin to be treated
with mild manual pressure using several wiping strokes
while carefully avoiding harsh irritating pressure.
When debriding is complete, after several gentle
wiping strokes,'the user would then apply the less abrasive
side of the same pad in an additional series of gentle
wiping strokes. The less abrasive side of the pad would
absorb dirt, oil and debris from the skin to be treated
which were debrided and loosened by wiping with the pad's
more abrasive side.
The foregoing dual series of wiping strokes serves the
additional function of depositing upon the skin to be
treated the material with which the pad was presaturated.
Typically, such material is the peeling and/or exfoliating
agent of the present invention, or the degreaser
composition, as more fully set forth elsewhere herein.
One of the most important novel features of the
present invention derives from the fact that its
concentrations of skin degreasing, exfoliating and/or
moisturizing agents is drastically reduced compared to
typical prior art compositions. As a consequence, the
present invention produces the desired skin degreasing,
exfoliating and moisturizing effects in a series of
painless treatments.
Prior art professional skin peeling not done in the
home has generally comprised the following sequence of
steps (1) cleansing the skin; (2) application of an
degreaser; (3) application of active skin peeling
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materials; and (4) neutralizing or removal of the active
skin peeling materials.
The present invention may utilize at least one of the
four steps, but with novel and very significant
modifications. An alternate modification may occur in step
2 with the use of (i) acetone in a home-use skin
preparation material and (ii) in the selectability of the
level of applicator pad abrasiveness. The novelty of step
3 may alternatively include (i) the use of acetone as a
skin penetrating agent, and (ii) the combination of a skin
degreasing, exfoliating and moisturizing agent composition
with a moisturizing material, which material is applied to
the skin to accomplish both gradual degreasing, exfoliating
and moisturizing at the same time.
In addition to the foregoing aspects of novelty, in
one embodiment of the present invention, the aforementioned
conventional four steps may be accomplished in a novel
manner. This alternate embodiment of the present invention
provides that the treatment steps be performed by applying
the given material by means of a cosmetic applicator pad
pre-saturated with the given material for the respective
steps 1-3, the pad further being selected to provide a
desired level of abrasive efficiency.
While it is known to use applicator pads of special
materials and construction to apply particular skin
exfoliating preparations, such as salicylic acid, the prior
art does not teach the use of cosmetic applicator pads with
specific abrasive capabilities, as does the present
invention. According to the present invention, applicator
pads with varying degrees of abrasive efficiency are
selectively provided in order to further control and vary
the depth of penetration of the degreasing, exfoliating
and/or moisturizing agents.
A given pad abrasion level may be selected from the
categories of mild and moderate abrasiveness according to
the present invention. Variation in applicator pad
abrasiveness is achieved by selecting suitable materials
for pad construction, such as cotton, nylon, polyester,
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styrene and the like, singly or in combination. The pad
may have an applicator surface which is of fibrous
consistency or otherwise suitably textured with a blend of
semi-rigid and soft materials for producing an abrasive
effect for scraping, removing and degreasing action.
The penetration depth and effectiveness of the
degreasing, exfoliating and/or moisturizing agents are
affected by pad abrasiveness because a given level of pad
abrasive capability results in mechanical exfoliation of
dead skin, thus exposing underlying living skin tissue more
effectively. By taking off the top layers of dead skin,
the alternative skin degreaser, such as acetone, is allowed
to work more effectively, providing a corresponding level
of skin degreasing efficiency when the skin is wiped with
the pad during the degreasing steps of treatment.
Pad abrasive efficiency thus controls the amount of
natural oil and grease left upon skin which has been
prepared for topical application of the degreasing,
exfoliating and/or moisturizing agent. The greater the
abrasive efficiency of the pad used for degreasing the
skin, the deeper the degreasing, exfoliating and/or
moisturizing agent will penetrate, thereby providing
enhanced degreasing, exfoliating and moisturizing agent
effectiveness.
The user of a pre-saturated cosmetic applicator pad
for a process of at least once per day applications gains
the convenience of being apply to accurately apply a
quantity of each respective materials in the 3 steps. Thus
predictable and desirable results are provided by the
present invention, in contrast to the prior art.
When a cosmetological applicator pad is used with the
composition of the present invention for use in the skin
exfoliating process, the exfoliating agent is:
(a) applied to the skin;
(b) allowed to effect its exfoliating activity; and
(c) debris is removed from the skin at essentially the
same time while leaving the composition of the present
invention on the skin to be treated.
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The result is a process very convenient for the user,
particularly in an at-home setting. In comparison to the
present invention, the prior art teaches nothing like the
application of a peeling and/or exfoliating agent which is
5 left on the skin and removal of skin cell debris.
An additional novel feature of the present invention
is that the exfoliating and/or degreasing or moisturizing
agents, once applied by the user, and left upon the skin
for at least several hours.
10 It is not neutralized, nor is it removed, because it
is a moisturizer. The present invention can be left on the
skin due its low concentration of gentle exfoliating and/or
moisturizing or degreasing agents. The present invention is
intended to be used, preferably at night before retiring,
15 so that the exfoliating and/or moisturizing or degreasing
agents would be left in contact with the user's skin until,
typically, washed off by normal bathing the next morning.
The present invention can also be applied in the morning,
and left on the skin all day.
In contrast, the prior art requires the application
followed by the relatively quick neutralization or removal
of exfoliating agents. This quick removal or
neutralization is obviously necessary due to the high
concentrations of exfoliating agents used in the prior art,
with their attendant harshness and action deep within the
skin and the wounding of living skin tissue.
Selecting the rate of skin degreasing, exfoliating
and/or moisturizing during use is accomplished by varying,
singly or in combination:
(a) applicator pad abrasivenss;
(b) degreaser composition, particularly with regard to
the concentration of acetone therein;
(c) treatment composition containing the degreasing,
exfoliating and moisturizing agents; and
(d) the number and frequency of treatments involving
the aforementioned steps.
It has been found that keeping the concentrations of
the exfoliating and/or moisturizing agents constant, and
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varying the type and concentration of the alternative
degreasing agent critically produces a change in the
degreasing, exfoliating and/or moisturizing rate.
It is thought that this is so because a more effective
degreaser, such as the alternative acetone component in the
degreaser composition in relatively high concentration will
be relatively more effective in removing skin surface oil,
thereby more effectively exposing underlying skin to contact
with the degreasing, exfoliating and moisturizing agents in
the treatment composition.
Acetone has not been used in home skin treatment
compositions in the prior art because it is far too harsh
and produces far too much skin drying. Thus, the prior art
has taught away from this critical novel feature of the
present invention.
However, because of the gentle moisturizing effect of
the glycolic acid in low concentrations in an applicator
pad, in the alternate embodiment with acetone, the normally
harsh effects of acetone are neutralized by the glycolic
acid. Thus, one is able to use acetone, in spite of its
harsh effects of use alone.
The degreasing, exfoliating and/or moisturizing agents
thereupon penetrate the skin deeper and more effectively
than if skin oils had been less efficiently removed. Also,
substituting alcohol as a degreaser in place of all or a
portion of acetone will affect, and thus control the rate of
cleaning, since alcohol is a less efficient solvent for skin
oil than is acetone. However, alcohol does not act as a
skin peeling agent as does acetone.
The degreaser composition of the present invention, as
elsewhere set forth, is typically a mixture of alcohol,
acetone and water. The concentrations of the degreaser
components in the degreaser composition can thus be varied
to produce a desired rate of skin degreasing, exfoliating
CA 02164229 2004-11-03
17
and moisturizing.
In preferred embodiments, the unit therapeutic dose per
presaturated applicator pad of the degreaser composition is
between about 0.20 grams and about 2.0 grams, preferably
between about .50 grams and about 1.0 grams.
In preferred embodiments, the unit therapeutic dose per
saturated applicator pad of the peeling composition is
between about 0.20 grams and about 2.0 grams, more
preferably between about .50 grams to about 1.0 grams.
The present invention provides an applicator pad for
treating skin conditions, such as aging skin, acne,
hyperpigmentation, sensitive skin, and composite dry-oily
skin. Applicator pads for the respective degreasing and/or
peeling steps are respectively saturated with a quantity of
degreasing, and exfoliating and/or moisturizing agents.
Each day of the course of treatment in a non-
professional setting the user applies the present
invention's materials at a selected frequency, for example,
at least once daily, for a selected duration of treatment,
for example, for a specified number of days, preferably 14
days, as indicated for each skin condition treatment as
follows:
In one embodiment, the skin is degreased by the user by
applying a degreaser with an applicator pad presaturated
with the degreasing material. The degreasing material
according to the present invention is set forth more
particularly in table 3 below. In particular, the degreaser
contains acetone in an aqueous base, which may also contain
alcohol.
The only necessary components of the peeling/
exfoliating agent of the present invention are AHAs, or
mixture thereof, of which the AHA is preferably glycolic
acid, and alternatively acetone as a degreaser, exfoliant
and moisturizer. The alpha hydroxy acids most effective for
CA 02164229 2004-11-03
17a
use in the present invention are glycolic acid, which is the
preferred AHA, and as well as lactic acid and pyruvic acid.
A related keto acid is also defined. These AHAs are not
equivalent to each other, since glycolic acid is gentler and
more effective than either lactic or pyruvic acids. In a
further alternative embodiment, the addition of a small
amount of salicylic acid may also be useful.
Lactic acid and pyruvic acid are harsher peeling and
exfoliating agents than is glycolic acid. The use of
lactic and pyruvic acids in a further alternative admixture
with glycolic acid in some embodiments is a feature of the
present invention, since the inclusion of lactic and/or
pyruvic acids can accelerate the peeling/exfoliating action
of the present invention. Other embodiments of the present
invention, as set forth above, provide a AHA selected from
CA 02164229 2004-11-03
18
the group consisting of glycolic, lactic and pyruvic acids
and mixtures thereof.
By varying both the absolute concentrations of the
1lfins selected for a particular embodiment of the present
invention, and/or selecting which AFiAs and in which
particular proportions they are to be used, a precisely
controlled degree of peeling/exfoliating efficacy can be
achieved.
Such controlled and precise peeling/exfoliating
efficacy is an important novel feature of the present
invention, since variations of the present invention will
permit the user to select a peeling composition which has a
particular combination of speed of peeling and.harshness.
It is to be noted that while it is an feature of the
present invention to provide a peel for at home use which
is both gradual and gentle, it is also necessary and
important to vary and to control the speed with which the
present invention achieves its results. Not only can speed
and efficacy be controlled as described, but speed and
efficacy can also be controlled by varying the frequency of
user application.
Thus, if a user doubles the frequency of application,
for example, applying the present invention twice daily
instead of once daily, the speed and efficacy will
naturally increase. However, it is once again emphasized
that rapidity of peeling action is not an object of the
present invention.
'I'tie following tables describe the peeling/exfoliating
compositions provided in the present invention. As has
been stated, the present invention provides low-
concentrations of AHAs and alternate ingredients, such as
acetone and salicylic acid in a cosmetic applicator pad.
Ttie AfiAs are provided in a suitable pharmaceutical vehicle,
which typically may be a composition according to the
tables presented below. It will be understood that a
suitable pharmaceutical vehicle is merely suggested by the
non-AIIA ingredients, and that other suitable pharmaceutical
veliicles wliich contain AliAs may also be used.
WO 94/27569 PCT/US94/06443
19
In the following tables, the inert, or inactive
ingredients, i.e., the ingredients not set forth above as
being active agents of the present invention represent the
composition of a preferred pharmaceutical vehicle for the
AHAs of the present invention.
Furthermore, certain tables below show representative
embodiments having specific combinations of AHAs. While
the preferred embodiment of the present invention provides
only glycolic acid as the AHA, it has been set forth above
that lactic and/or pyruvic acids may also be included
singly or in combination with each other and/or in
combination with glycolic acid or optionally in combination
with acetone and/or salicylic acid. It will be understood
that tables below specifying combinations of the
aforementioned AHAs are merely exemplary and are not
intended to be exclusive or to limit the scope of the
present invention.
The following tables describe the peeling/exfoliating
compositions provided in the present invention as well as
an alternative acetone-containing degreaser composition.
As has been stated, the present invention provides low-
concentrations of AHAs in a cosmetic applicator pad. The
AHAs are provided in a suitable pharmaceutical vehicle,
which typically may be a composition according to the
tables presented below. It will be understood that a
suitable pharmaceutical vehicle is merely suggested by the
non-AHA ingredients, and that other suitable pharmaceutical
vehicles which contain AHAs may also be used.
In the following tables, the inert, or inactive
ingredients, i.e., the ingredients not set forth above as
being active agents of the present invention represent the
composition of a preferred pharmaceutical vehicle for the
AHAs of the present invention.
Furthermore, the alternative acetone degreaser
composition is separately provided in a presaturated
cosmetic applicator pad to be used prior to and separately
from the cosmetic applicator pad saturated with the gentle
CA 02164229 2004-11-03
peeling and/or exfoliating composition of the present
invetition.
Furthermore, certain tables below show representative
enibodiments of the treatment composition having specific
combitiations of AliAs, and optionally, acetone and/or
salicylic acid. It has been set forth above that lactic
and/or pyruvic acids may also be included singly or in
combination with each other and/or in combination with
glycolic acid and optionally with acetone and/or salicylic
10 acid. It will be understood that tables below specifying
combinations of the aforementioned AliAs are merely
exemplary and are not intended to be exclusive or to limit
ttie scope of the present invention.
Table 1
Composition Showing the AHAs of the Present Invention With
Non-AIIA Materials Comprising An Exemplary Preferred
Pharinaceutical Vehicle
Materials are listed by Weight Percentages
Material From About To About
20 Disodium EDTA 0.0 0.3%
Sodium Benzoate 0.0 0.4%
Witch Iiazel E02 0.0 98%
Polysorbate-20 0.0 10%
nlptia hydroxy acid An effective amount 20%
Ammonia, dissolved 0.0 5%
*Germall 115 0.0 0.5%
Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition 100.0%
Table 2
Composition for Exfoliating and Moisturizing Agents of the
Present Invention Showing Preferred Concentrations of AHAs
Materials are listed by Weight Percentages
1-taterial Preferably From About To About
Uisodium EDTA 0.080% 0.13%
Sodiuni Benzoate 0. 15 0 0. 3 0
Witch Iiazel E02 1% 5%
Polysorbate-20 0.5% 2.5%
*Trade-mark
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Alpha hydroxy acid 3.0% 7.5%
Ammonia, dissolved 0.3% 1%
Germall 115 0.15% 0.3%
Acetone 0.25% 4.0%
Alcohol 2.5% 7.5%
Purified Water Balance of Composition to 100%
Table 3
Preferred Alternative Degreaser Composition
Materials are listed by Weight Percentages
Material From About To About
Witch Hazel 0.0% 25%
Propylene Glycol 0.0% 25%
Camphor 0.0% 5%
Acetone 0.1% 10%
Alcohol 0.0% 80%
Sodium Borate 0.0% 1%
Purified Water Balance of Composition 100.0%
Table 4
Degreaser Composition Preferred Acetone Concentrations
Materials are listed by Weight Percentages
Preferably From About To About
Witch Hazel 1% 3%
Propylene Glycol 1% 6%
Camphor 0.01% 0.75%
Acetone 1% 7%
Alcohol 30% 65%
Sodium Borate 0.01% 0.75%
Purified Water Balance to 100.0%
Tables 5-8 below show specific exemplary embodiments
of the present invention. Tables 5-8 are based upon Table
1, varying only in that specific AHAs are shown and are not
intended to limit the scope of the present invention.
Furthermore, preferred concentration ranges are shown in
Table 2 above, and these preferred concentrations apply to
Tables 5-8 below.
Table 5
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22
Composition Showing Glycolic Acid as the AHA of the Present
Invention With Non-AHA Materials Comprising An Exemplary
Preferred Pharmaceutical Vehicle
Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0 0.3%
Sodium Benzoate 0.0 0.4%
Witch Hazel E02 0.0 98%
Polysorbate-20 0.0 10%
Glycolic acid An effective amount 20%
Ammonia, dissolved 0.0 5%
Germall 115 0.0 0.5%
Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition 100.0%
Table 6
Composition Showing Glycolic Acid Admixed with Lactic Acid
as an Example of an AHA Combination of the Present
Invention With Non-AHA Materials Comprising An Exemplary
Preferred Pharmaceutical Vehicle
Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0 0.3%
Sodium Benzoate 0.0 0.4%
Witch Hazel E02 0.0 98%
Polysorbate-20 0.0 10%
Mixed glycolic and
lactic acids An effective amount 20%
Ammonia, dissolved 0.0 5%
Germall 115 0.0 0.5%
Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition 100.0%
Table 7
Composition Showing Glycolic Acid Admixed with Pyruvic Acid
as an Example of an AHA Combination of the Present
Invention With Non-AHA Materials Comprising An Exemplary
Preferred Pharmaceutical Vehicle
WO 94/27569 PCT/US94/06443
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Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0 0.3%
Sodium Benzoate 0.0 0.4%
Witch Hazel E02 0.0 98%
Polysorbate-20 0.0 10%
Mixed glycolic and
pyruvic acids An effective amount 20%
Ammonia, dissolved 0.0 5%
Germall 115 0.0 0.5%
Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition 100.0%
Table 8
Composition Showing Glycolic Acid Admixed with Lactic and
Pyruvic Acids as an Example of an AHA Combination of the
Present Invention With Non-AHA Materials Comprising An
Exemplary Preferred Pharmaceutical Vehicle
Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0 0.3%
Sodium Benzoate 0.0 0.4%
Witch Hazel E02 0.0 98%
Polysorbate-20 0.0 10%
Mixed glycolic and An effective amount 20%
lactic and pyruvic acids
Ammonia, dissolved 0.0 5%
Germall 115 0.0 0.5%
Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition 100.0%
In the degreaser composition, the concentrations of
the acetone, alcohol and acetone may be varied, since the
acetone is an aggressive solvent for removing residual oils
on the skin and also acts as a peeling agent in its own
right. The higher the acetone concentration, the more
rapidly the composition of the present invention will
achieve its results.
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24
By reducing the alternative acetone concentration in
relation to the relative proportions of alcohol and/or
water in the degreaser, in view of the fact that neither
alcohol nor water act as skin peeling agents, a gentler
degreasing effect is achieved. In addition, the peeling
effect of the acetone present in the degreaser will
correspondingly be controlled and reduced as the acetone
concentration is reduced.
Use of the present invention is accomplished by wiping
with mild manual pressure a cosmetic applicator pad
presaturated with at least one AHA composition over the
skin to be treated. The applicator pad debrides the skin
of dead skin, dead skin cell debris, dirt, and oil, all of
which are removed by and remain upon the pad. As the pad
is wiped across the skin to be treated, the mild manual
pressure expresses the AHA composition and deposits the
same topically upon the skin. Because the skin has been
debrided and prepared by removal of debris dirt and oil,
the AHAs are permitted access to penetrate the skin and
thus to accomplish their peeling and/or exfoliating
activity.
With or without an alternative first step of
degreasing, as set forth above, the next step is the
application to the skin of exfoliating and/or peeling
material according to the present invention. The peeling
agent is applied with an applicator pad presaturated
therewith applied to the skin to be treated. The
applicator pad is provided with a preselected level of
abrasiveness selected from the group consisting of mild
abrasiveness, moderate abrasiveness and strong
abrasiveness.
The user exercises care in the application of moderate
manual pressure to the applicator pad as it passes over the
skin to be treated so as to provide a mild and/or moderate
abrading of said skin.
The preferred embodiment of the composition of the
present invention is presented in Table 9 below. Table 10
sets forth preferable concentrations. The preferred
WO 94/27569 21642 2 9 PCT/US94/06443
embodiment comprises the AHA glycolic acid combined with
acetone and inert ingredients. The inert or inactive
ingredients provide a suitable pharmaceutical base for the
peeling agents, but do not provide a skin peeling or
5 exfoliating action. The inert ingredients may be
substituted with equivalent materials for producing a
suitable pharmaceutical base.
However, since the only necessary components are
glycolic acid as a degreaser, exfoliant and/or moisturizer,
10 and alternatively acetone as a degreaser, the composition
may be also defined as in the alternate range shown in
Table 9 below, or as in an alternate preferred composition
as in Table 10 below.
Table 9
15 Alternate Composition for Exfoliating and Moisturizing
Agents of the Present Invention
Materials are listed by Weight Percentages
Material From About To About
Alpha hydroxy acid An effective amount 20%
20 Acetone 0.0 10%
Alcohol 0.0 98%
Purified Water Balance of Composition to 100.0%
Table 10
Alternate Composition for Exfoliating and Moisturizing
25 Agents of the Present Invention Preferred Concentrations
Materials are listed by Weight Percentages
Material Preferably From About To About
Alpha hydroxy acid An effective amount 7.5%
Acetone 0.0% 10%
Alcohol 0.0 98%
Purified Water Balance of Composition to 100%
The present invention provides respective kit
assemblies for treating the respective skin conditions set
forth above. Each respective kit assembly includes an
effective and convenient instructional means, such as an
instructional pamphlet or a videotape or other
instructional means containing thereon indicia for
administration of sequentially applied components according
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26
to steps needed for the respective skin condition to be
treated.
The kit assembly also provides a sequential dispenser
means containing a plurality of daily sets of kit sub-
assembly components, such as a series of jars containing a
supply of presaturated applicator pads having,
respectively, cleanser, degreaser and peeling agent
therein. In addition, kits are provided with containers
such as bottles or tubes of other non-pad-requiring
ingredients for the respective skin conditions, such non-
pad-requiring materials being, for example, a moisturizer,
a sun screen, etc as more fully set forth below. In
addition to respective kits being specific for treatment of
each aforementioned skin condition, kits are further
respectively specific with regard to whether a given kit is
to be used for the therapeutic phase or, in the
alternative, for the maintenance phase.
Generally, and except as set forth for specific skin
conditions in more detail below, each kit provided in the
present invention has sub-assembly components including
therein the following:
a. a step 1 container including a supply of
applicator pads saturated with a premeasured quantity of a
non-soaping non-detergent cleanser lotion; the supply
includes two such pads for each day of intended use, one
for a morning use and one for an evening use e.g., 14 step-
1 pads for 7 days of intended use, for example, in the
therapeutic phase.
Since the maintenance phase is intended to be used
following the preferably 7-day therapeutic phase, and to
provide daily maintenance treatments for one month, the
corresponding maintenance kit would preferably contain 60
step-i cleansing pads for 30 days of intended twice-daily
maintenance treatments. The remaining saturated pad
descriptions below are similarly intended to be understood
to apply, respectively to a preferably therapeutic phase of
7 days and a preferably maintenance phase of 30 days.
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27
b. a step-2 container including a supply of
applicator pads saturated with a premeasured quantity of
degreaser.
c. a step-3 container including a supply of
applicator pads saturated with a premeasured quantity of
peeling/exfoliating exfoliating agent.
d. a step-4 container such as a tube or bottle
containing a post-treatment moisturizing and anti-
inflammatory material.
e. a step-5 container such as a tube or bottle
containing a moisturizing sun screen material.
f. for certain skin conditions, a suitable step 6
container such as a tube or bottle with a required
material, as detailed below.
Each day of the course of treatment, one component of
the kit assembly is used for both applying and removing the
agents in a non-professional setting according to the
aforementioned steps, which are performed at selected
periodic intervals, e.g., once daily by the user as
directed by the instructions for the particular kit for the
particular respective skin condition for the particular
respective number of days of that kit's embodiment [e.g.,
7-day therapy phase treatment kit for aging skin]. The
step-wise procedure employed by the user is generally
described in further detail as follows:
a. step 1- cleansing the skin to be treated with a
non-soaping non-detergent cleanser lotion applied with an
applicator pad having a preselected level of abrasiveness,
said pad being wiped across the skin to be treated with
mild manual pressure;
b. step 2 - applying a suitable degreasing agent to
degrease the skin to be treated, the degreasing agent being
applied with an applicator pad having a preselected level
of abrasiveness and the pad being presaturated with a
measured quantity of degreasing agent in the manner set
forth in step "a";
c. step 3 - applying to the skin to be treated a
composition of mild skin peeling agents of a composition
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28
elsewhere described herein, with an applicator pad
presaturated with a measured quantity of said skin peeling
agents in the manner set forth in step "a", the user
exercising care in the application of moderate manual
pressure to the applicator pad as it passes over the skin
to be treated so as to provide a mild abrading of said
skin; and
d. step 4 - applying a suitable moisturizing anti-
inflammatory cream to the skin to be treated.
e. step 5 - applying a special sun screen.
The present invention provides three types of
moisturizing sun screens.
Type 1 - employs a hydro-alcoholic gel for acne
patients, because this is a drying-type sun screen.
Type 2 employs a rich moisturizing sun screen for
the photo aging skin and aging skin.
Type 3 - employs a bleaching agent - hydroquinone -
for hyperpigmented and darkly pigmented skin.
Skin bleaching is separately provided by the present
invention as a separate step for the pigmented skin, i.e.,
hyperpigmented skin and darkly pigmented skin. Bleaching
would be done by applying a hydroquinone bleach-containing
material in the evening. The hydroquinone bleach, as
described in more detail below, is applied after the
peeling agent has been applied and before the moisturizer
is applied. Thus, the peeling/exfoliating exfoliating
agent, the hydroquinone bleach, and the moisturizer are all
left on the skin to be treated all night long.
The present invention provides two types of anti-
inflammatory moisturizer materials. Both have
hydrocortisone in them.
Type 1 - anhydrous preparation employed for aging
skin.
Type 2 - hydrous preparation used for all other skin
types.
The skin peeling/exfoliating exfoliating agents
provided in step 3 of the present invention include low
concentrations of, preferably, acetone, glycolic acid,
WO 94/27569 PCT/US94/06443
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29
salicylic acid, and lactic acid according to the Tables set
forth below. In an alternate embodiment, a low-
concentration quantity of resorcinol is provided as a
peeling/exfoliating exfoliating agent in combination with
the aforementioned preferable peeling agents. The preferred
embodiment of the composition of the peeling/exfoliating
exfoliating agent of the present invention is presented in
Table 1 below, and the alternate embodiment composition
containing resorcinol is presented in Table 2 below. Tables
1.1 and 2.1, respectively, set forth ranges and preferable
concentrations for the therapeutic phase of the present
invention, namely the 15-2-2 peeling/exfoliating
exfoliating composition. 15-2-2 refers to preferably 15%
glycolic acid, 2% lactic acid and 2% salicylic acid. The
Maintenance phase preferably utilizes 5-2-2, i.e., one-
third the concentrations of the aforementioned
peeling/exfoliating exfoliating agents. The compositions
and concentrations of the maintenance phase
peeling/exfoliating exfoliating agents are not here set
forth because they are the same as those set forth in
Tables 1, 1.1, 2, and 2.1, except that, instead of the 15-
2-2 composition, the maintenance phase uses a 5-2-2
composition.
Table 11
Composition of Peeling/exfoliating exfoliating Agents
of an Embodiment of the Therapeutic Phase
of the Present Invention
Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0% 0.3%
Sodium Benzoate 0.0% 1.0%
Witch Hazel E02 0.0% 20%
Polysorbate-20 0.0% 25%
Salicylic acid USP 0.1% 5%
lactic acid USP 0.1% 20%
Glycolic acid 0.1% 20%
Ammonia, dissolved 0.0% 35%
Germall 115 0.0% 1.0%
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Acetone 0.1% 10%
Alcohol 0.0% 50%
Water Balance of Composition 100.0%
Table 12
Composition of Peeling/exfoliating exfoliating Agents of an
Embodiment of the Therapeutic Phase of the Present Showing
Preferred Concentrations
Materials are listed by Weight Percentages
Material Preferably About
Disodium EDTA 0.1%
Sodium Benzoate 0.2%
Witch Hazel E02 2.5%
Polysorbate-20 1.0%
Salicylic acid USP 2.0%
Lactic acid USP 2.0%
Glycolic acid 15.0%
Ammonia, dissolved 6.0%
Germall 115 0.2%
Acetone 5.0%
Alcohol 5.0%
Purified Water Balance of Composition to 100%
Table 13
Composition of Peeling/exfoliating exfoliating Agents of an
Alternate Embodiment of the Therapeutic Phase of the
Present Invention With Resorcinol
Materials are listed by Weight Percentages
Material From About To About
Disodium EDTA 0.0% 0.3%
Sodium Benzoate 0.0% 1.0%
Witch Hazel E02 0.0% 20%
Polysorbate-20 0.0% 25%
Salicylic acid USP 0.1% 5%
Lactic acid USP 0.1% 20%
Glycolic acid 0.1% 20%
Resorcinol 0.1% 10%
Ammonia, dissolved 0.% 35%
Germall 115 0.0% 1.0%
Acetone 0.1% 10%
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Alcohol 0.0% 50%
Water Balance of Composition 100.0%
Table 14
Composition of Peeling/exfoliating exfoliating Agents of an
Alternate Embodiment of the Therapeutic Phase of the
Present Invention With Resorcinol
Same As Table 2, Showing Preferred Concentrations
Materials are listed by Weight Percentages
Material Preferably About
Disodium EDTA 0.1%
Sodium Benzoate 0.2%
Witch Hazel E02 2.5%
Polysorbate-20 1.0%
Salicylic acid USP 2.0%
Lactic acid USP 2.0%
Glycolic acid 15.0%
Resorcinol 2.0%
Ammonia, dissolved 6.0%
Germall 115 0.2%
Acetone 5.0%
Alcohol 5.0%
Purified Water Balance to 100.0%
Table 15
Composition of Degreaser Composition of the Present
Invention
Materials are listed by Weight Percentages
Material From About To About
Witch Hazel 0.0% 25%
Propylene Glycol 0.0% 25%
Camphor 0.0% 5%
Acetone 0.1% 10%
Alcohol 1.0% 80%
Sodium Borate Trace 1%
Water Balance of Composition 100.0%
Table 16
Composition of Step 2 - Degreaser Composition of the
Present Showing Preferred Concentrations
Materials are listed by Weight Percentages
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Material Preferably About
Witch Hazel 2.5%
Propylene Glycol 3.0%
Camphor 0.1%
Acetone 5.0%
Alcohol 51%
Sodium Borate 0.1%
Purified Water Balance to 100.0%
The following specific compositions are provided for
treatment of the respective skin conditions. For example,
in the therapy phase of acne treatment, step 1 cleanser is
listed as provided in saturated pads in a 2 ounce quantity.
In like manner, all other listed component quantities are
similarly divided evenly into subquantities for pad
saturation for the relevant number of days.
It should be noted that, for the treatment of
hyperpigmented skin and darkly pigmented skin, there are 6
steps provided, the sixth step being application of a sun
screen in the morning and the fifth step being application
of a moisturizer and anti-inflammatory combination in the
evening. The active anti-inflammatory ingredient of the
present invention is hydrocortisone. As set forth above,
the individual treatments of the respective skin conditions
in some cases require more than four steps. In addition,
there is a separate morning and evening treatment for each
respective skin condition. The individual skin conditions
are treated generally as follows.
Aging and Photo-Aging Skin - Therapy Phase
1. Cleansing twice daily is accomplished with a soap-
free cleansing lotion designed to cleanse efficiently
without excessive drying or irritation of the skin. A
cleanser such as DEA lauryl sulfate in an emollient base
and is used twice per day.
2. The degreaser is applied to deep clean the skin
and remove excess sebum, which may reduce the effectiveness
of the treatment pads. The degreaser is a hydro-alcoholic
solution containing acetone in the concentration range of
0.1% to 10% but preferably 5% .
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33
3. 15-2-2 Treatment Pads contain the peeling/
exfoliating agent combination glycolic acid [preferably
15%, but over the possible range of 1-20%], salicylic acid
[preferably 2%, but over the possible range of 0.1% to 5%],
and lactic acid [preferable 2%, but over a possible range
of 0.1% to 20%]. The 15-2-2 combination works
synergistically with acetone as a peeling agent [preferably
5% but over the possible range of 0.1% to 10%]. The
peeling/exfoliating agent combination is provided in a
penetrating hydro-alcoholic vehicle containing acetone as a
co-solvent to insure proper delivery of the peeling/
exfoliating agent to the skin area to be treated. See
Tables 1 and 2 for compositions and concentration ranges.
4. After the peeling/exfoliating treatment, the
hydrocortisone balm for night-time use only is applied,
containing the well-known anti-inflammatory and anti-
pruritic drug hydrocortisone in the concentration range
0.1% to 2.5%, preferably 1%, in an anhydrous base.
5. A moisturizing sun screen is provided for morning
application and day-time use to replenish moisture to the
skin and maintain the moisture balance of the skin. The
moisturizing sun screen is further provided with broad
spectrum UV screens [i.e., screens for UVA and UVB] for
protection from sunlight after therapy. The moisturizing
sun screen contains octyl methoxycinnamate in the
concentration range of 1.5% - 7.5%, preferably 7.5% and
benzophenone-3 in the range from 0.1% to 6%, preferably 4%.
Aging Skin and Photo-Aging - Maintenance Phase
1. cleansing twice daily is accomplished with a soap-
free cleansing lotion designed to cleanse efficiently
without excessive drying or irritation of the skin. A
cleanser such as DEA lauryl sulfate in an emollient base
and is used twice per day.
2. The degreaser is applied twice daily to deep clean
the skin and remove excess sebum, which may reduce the
effectiveness of the treatment pads. The degreaser is a
hydro-alcoholic solution containing acetone in the
concentration range of 0.1% to 10% but preferably 5%
WO 94/27569 PCT/US94/06443
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3. Gentle twice daily peeling/exfoliation is
accomplished by the use of the 5-2-2 treatment pad during
the maintenance phase. The 5-2-2 pad contains glycolic
acid [preferably 5%, but over a possible range of 1-20%],
salicylic acid [preferably 2%, but over a possible range of
0.1% to 5%], and lactic acid [preferably 2%, but over a
possible range of 0.1% to 20%]. The peeling/ exfoliating
agent combination is carried in a penetrating hydro-
alcoholic vehicle containing acetone in the concentration
range of 0.1% to 10% but preferably 5% as a co-solvent to
insure proper delivery of the peeling/ exfoliating agent to
the skin area to be treated. See Tables 1 and 2 for
compositions and concentration ranges.
4. After the peeling/exfoliating step, the
hydrocortisone balm is applied at night time, containing
the well-known anti-inflammatory and anti-pruritic drug
hydrocortisone in the concentration range 0.1% to 2.5%
preferably 1% in a hydrous base.
5. A moisturizing sun screen is provided for morning
application and day-time use to replenish moisture to the
skin and maintain the moisture balance of the skin. The
moisturizing sun screen is further provided with broad
spectrum UV screens [i.e., screens for UVA and UVB] for
protection from sunlight after therapy. The moisturizing
sun screen contains octyl methoxycinnamate in the
concentration range of 1.5% - 7.5%, preferably 7.5% and
benzophenone-3 in the range from 0.1% to 6%, preferably 4%.
Sensitive Skin - Therapy Phase
For sensitive skin, the therapy phase is comprised of
the following steps:
1. cleansing is accomplished with a soap-free
cleansing lotion designed to cleanse efficiently without
excessive drying or irritation of the skin. A cleanser
such as DEA lauryl sulfate in an emollient base and is used
twice per day.
2. The skin is degreased gently, without excessive
abrasion or further use of detergents or solvents. The
skin further cleansed using ultra pure rehydrated aloe vera
WO 94/27569 PCT/US94/06443
2164229
juice and a blend of sodium PCA and other humectants, such
as methyl glyceth-20 in a water-based vehicle.
3. 15-2-2 Treatment Pads contain the
peeling/exfoliating agent combination glycolic acid
5[preferably 15%, but over the possible range of 1-20%],
salicylic acid [preferably 2%, but over the possible range
of 0.1% to 5%], and lactic acid (preferable 2%, but over a
possible range of 0.1% to 20%]. The peeling/exfoliating
agent combination is provided in a penetrating hydro-
10 alcoholic vehicle containing acetone as a co-solvent to
insure proper delivery of the peeling/exfoliating agent to
the skin area to be treated. The 15-2-2 combination works
synergistically with acetone as a peeling agent [preferably
5% but over the possible range of 0.1% to 10%]. See Tables
15 1 and 2 for compositions and ranges.
The penetrating effect refers to the ability of the
vehicle to cause deep, even dispersion throughout the skin.
A hydro-alcoholic vehicle is one containing both water and
alcohol, comprising a two-solvent system.
20 4. The therapeutic balm, which is applied twice daily
contains the well-known anti-inflammatory and anti-pruritic
drug hydrocortisone in the range of 0.1% to 2.5% in a
hydrous base. The therapeutic balm serves to promote
hydration and reduce inflammation to increase user comfort,
25 as may be needed with frequent treatment of sensitive skin.
5. Moisturization and Ultraviolet light [UV]
protection is provided for morning and daytime use on
sensitive skin by applying a quick absorbing oil free
emulsion which is light in consistency and does not have a
30 heavy or oily base. Broad spectrum [UVA and UVB] protection
is provided without the use of oxybenzone, lanolins,
glycols, etc. The UV filters are Octyl Methoxycinnamate in
the range of 1.5% to 7.5% and Menthyl Anthranilate in the
range of 1% to 10% and the oil-free emulsion itself is a
35 water-based emulsion comprised of a water-based vehicle and
an ester-based emollient phase.
Sensitive Skin - Maintenance Phase
WO 94/27569 PCT/US94/06443
36
For sensitive skin, the Maintenance phase is comprised
of the following:
1. Soap-free cleansing twice daily is done during the
maintenance phase. Cleansing is accomplished with a soap-
free cleansing lotion as in the therapy phase, the cleanser
being designed to cleanse efficiently without excessive
drying or irritation of the skin.
2. The skin is degreased gently twice daily, without
excessive abrasion or further use of detergents or
solvents. The skin further cleansed using ultra pure
rehydrated aloe vera juice and a blend of sodium PCA and
other humectants, such as methyl glyceth-20 in a water-
based vehicle.
3. Gentle twice daily peeling/exfoliation is
accomplished by the use of the 5-2-2 treatment pad during
the maintenance phase. The 5-2-2 pad contains glycolic
acid [preferably 5%, but over a possible range of 1-20%],
salicylic acid [preferably 2%, but over a possible range of
0.1% to 5%], and lactic acid [preferably 2%, but over a
possible range of 0.1% to 20%]. The peeling/ exfoliating
agent combination is carried in a penetrating hydro-
alcoholic vehicle containing acetone in the concentration
range of 0.1% to 10% as a co-solvent to insure proper
delivery of the peeling/ exfoliating agent to the skin area
to be treated. The 5-2-2 combination works synergistically
with acetone as a peeling agent [preferably 5% but over the
possible range of 0.1% to 10%]. See Tables 1 and 2 for
compositions and concentration ranges.
4. After the peeling/exfoliating treatment, the
therapeutic hydrocortisone balm is applied, containing the
well-known anti-inflammatory and anti-pruritic drug
hydrocortisone in the concentration range 0.1% to 2.5% but
preferably 1%, in a hydrous base.
5. Sun protector is applied in the morning for day
time use via quick absorbing, oil-free emulsion for
sensitive skin. Broad spectrum [UVA and UVB] protection is
provided without the use of oxybenzone, lanolins, glycols,
etc. The UV filters are Octyl Methoxycinnamate in the
WO 94/27569 PCT/US94/06443
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37
range of 1.5% to 7.5% and Menthyl Anthranilate in the range
of 1% to 10% and the oil-free emulsion itself is a water-
based emulsion comprised of a water-based vehicle and an
ester-based emollient phase.
Acne Treatment - Therapy Phase
1. Cleansing twice daily is accomplished with a soap-
free cleansing lotion designed to cleanse efficiently
without excessive drying or irritation of the skin. A
cleanser such as DEA lauryl sulfate in an emollient base
and is used twice per day.
2. The degreaser is applied to deep clean the skin
and remove excess sebum, which may reduce the effectiveness
of the treatment pads. The degreaser is a hydro-alcoholic
solution containing acetone in the concentration range of
0.1% to 10% but preferably 5%
3. 15-2-2 Treatment Pads contain the
peeling/exfoliating agent combination glycolic acid
[preferably 15%, but over the possible range of 1-20%],
salicylic acid [preferably 2%, but over the possible range
of 0.1% to 5%], and lactic acid [preferable 2%, but over a
possible range of 0.1% to 200]. The peeling/exfoliating
agent combination is provided in a penetrating hydro-
alcoholic vehicle containing acetone as a co-solvent to
insure proper delivery of the peeling/exfoliating agent to
the skin area to be treated. The 15-2-2 combination works
synergistically with acetone as a peeling agent [preferably
5% but over the possible range of 0.1% to 10%]. See Tables
1 and 2 for compositions and concentration ranges.
4. A hydrocortisone moisturizer therapeutic balm is
applied which is used at night time. This material uses
the well-known anti-inflammatory hydrocortisone in a water-
based emulsion.
5. A gel containing a topical acne preparation or
group of preparations such as benzoyl peroxide is then
applied in the morning, but not at night. Appropriate
directions are provided in the kit of the present
invention. The use of benzoyl peroxide to treat acne is
WO 94/27569 PCT/US94/06443
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38
well documented. This gel provides benzoyl peroxide U.S.P.
in a non-irritating water based gel.
6. An acne treatment UV screen for morning
application and daytime use is provided to reduce the
user's UV exposure. The acne UV screen is a non-
comedogenic, oil-free preparation containing octyl
methoxycinnamate in the concentration range of 1.5% - 7.5%
, preferably 7.5%; homosalate 1-10%, preferably 5%; octyl
salicylate 1.5-5%, preferably 5%; and benzophenone-3 in the
range from 0.1% to 6%, preferably 4% to provide broad
spectrum UVA and UVB protection in a hydro-alcoholic base.
The user is instructed to use the acne UV screen liberally,
i.e., to totally cover the area of therapy with the UV
screen.
Acne Treatment - Maintenance Phase
1. An antiseptic acne cleanser is provided which
contains mild detergents to cleanse the skin and remove
excess oil. The user is instructed to cleanse the skin at
regular periodic intervals, preferably twice per day.
2. Gentle twice daily peeling/exfoliation is
accomplished by the use of the 5-2-2 treatment pad during
the maintenance phase. The 5-2-2 pad contains glycolic
acid [preferably 5%, but over a possible range of 1-20%],
salicylic acid [preferably 2%, but over a possible range of
0.1% to 5%), and lactic acid [preferably 2%, but over a
possible range of 0.1% to 20%]. The peeling/exfoliating
agent combination is carried in a penetrating hydro-
alcoholic vehicle containing acetone in the concentration
range of 0.1% to 10% as a co-solvent to insure proper
delivery of the peeling/exfoliating agent to the skin area
to be treated. The 5-2-2 combination works synergistically
with acetone as a peeling agent [preferably 5% but over the
possible range of 0.1% to 10%]. See Tables 1 and 2 for
compositions and concentration ranges.
3. A gel containing a topical acne preparation or
group of acne preparations, such as benzoyl peroxide is
then applied twice daily in the morning, and at night, as
per kit instructions.
WO 94/27569 PCT1US94/06443
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39
4. An acne treatment W screen for morning
application and daytime use is provided to reduce the
user's UV exposure. The acne UV screen is a non-
comedogenic, oil-free preparation containing octyl
methoxycinnamate in the concentration range of 1.5% - 7.5%
preferably 7.5%; homosalate 1-10%, preferably 5%; octyl
salicylate 1.5-5%, preferably 5%; and benzophenone-3 in the
range from 0.1% to 6%, preferably 4% to provide broad
spectrum UVA and UVB protection in a hydro-alcoholic base.
The user is instructed to use the acne UV screen liberally,
i.e., to totally cover the area of therapy with the UV
screen.
5. Evening-use Hydrocortisone Moisturizer therapeutic
balm - this material uses the well-known anti-inflammatory
hydrocortisone in a water-based emulsion.
Hyper Pigmented Skin and Darkly Pigmented Skin
- Therapy Phase
1. Cleansing twice daily is provided by the soap-free
cleanser during the maintenance phase. Cleansing is
accomplished with a soap-free cleansing lotion as in the
therapy phase, the cleanser being designed to cleanse
efficiently without excessive drying or irritation of the
skin.
2. The degreaser is applied to deep clean the skin
and remove excess sebum, which may reduce the effectiveness
of the treatment pads. The degreaser is a hydro-alcoholic
solution containing acetone in the concentration range of
0.1% to 10% but preferably 5% .
3. 15-2-2 Treatment Pads contain the peeling/
exfoliating agent combination glycolic acid [preferably
15%, but over the possible range of 1-20%], salicylic acid
[preferably 2%, but over the possible range of 0.1% to 5%],
and lactic acid [preferable 2%, but over a possible range
of 0.1% to 20%]. The peeling/exfoliating agent combination
is provided in a penetrating hydro-alcoholic vehicle
containing acetone as a co-solvent to insure proper
delivery of the peeling/exfoliating agent to the skin area
to be treated. The 15-2-2 combination works
WO 94/27569 PCT/US94/06443
2164229
synergistically with acetone as a peeling agent [preferably
5% but over the possible range of 0.1% to 10%]. See Tables
1 and 2 for compositions and concentration ranges.
4. Hydroquinone screen cream is provided for
5 application to areas of hyperpigmentation or generally to
darkly pigmented skin at a selected interval, between two
and four times daily, preferably three times. An alternate
embodiment includes a hydro-alcoholic vehicle at night with
the hydroquinone screen used in the morning. This
10 hydroquinone screen cream contains hydroquinone in the
range of 0.1% to 2%, preferably 2% as a skin bleach in a
non-comedogenic water based emulsion. Also provided in the
hydroquinone screen cream is a broad spectrum [UVA and UVB]
sunscreen, preferably octylmethoxycinnamate, and preferably
15 about 7.5% and benzophenone-3, preferably about 1.5%. and
emollients and moisturizers .
5. Therapeutic balm for night-time use. After the
peeling/ exfoliating treatment, the therapeutic
hydrocortisone balm is applied at night time, containing
20 the well-known anti-inflammatory and anti-pruritic drug
hydrocortisone in the concentration range 0.1% to 2.5%
preferably 1% in a hydrous base.
6. Moisturization and Ultraviolet light [UV]
protection is provided for sensitive skin by applying a
25 quick absorbing oil free emulsion which is light in
consistency and does not have a heavy or oily base. Broad
spectrum [UVA and UVB] protection is provided without the
use of oxybenzone, lanolins, glycols, etc. The UV filters
are Octyl Methoxycinnamate in the range of 1.5% to 7.5% and
30 Menthyl Anthranilate in the range of 1% to 10% and the oil-
free emulsion itself is a water-based emulsion comprised of
a water-based vehicle and an ester-based emollient phase.
Hyper Pigmented Skin and Darkly Pigmented Skin
- Maintenance Phase
35 1. Cleansing twice daily is provided by the soap-free
cleanser during the maintenance phase. Cleansing is
accomplished with a soap-free cleansing lotion as in the
therapy phase, the cleanser being designed to cleanse
WO 94/27569 PCT/US94/06443
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41
efficiently without excessive drying or irritation of the
skin.
2. The degreaser is applied twice daily to deep clean
the skin and remove excess sebum, which may reduce the
effectiveness of the treatment pads. The degreaser is a
hydro-alcoholic solution containing acetone in the
concentration range of 0.1% to 10% but preferably 5%
3. Gentle twice daily peeling/exfoliation is
accomplished by the use of the 5-2-2 treatment pad during
the maintenance phase. The 5-2-2 pad contains glycolic
acid [preferably 5%, but over a possible range of 1-20%],
salicylic acid [preferably 2%, but over a possible range of
0.1% to 5%], and lactic acid [preferably 2%, but over a
possible range of 0.1% to 20%]. The peeling/exfoliating
agent combination is carried in a penetrating hydro-
alcoholic vehicle containing acetone in the concentration
range of 0.1% to 10% as a co-solvent to insure proper
delivery of the peeling/ exfoliating agent to the skin area
to be treated. The 5-2-2 combination works synergistically
with acetone as a peeling agent [preferably 5% but over the
possible range of 0.1% to 10%]. See Tables 1 and 2 for
compositions and concentration ranges.
4. Hydroquinone screen cream is provided for
application at a selected interval, between two and four
times daily, preferably three times to pigmented areas. An
alternate embodiment includes a hydro-alcoholic vehicle at
night with the hydroquinone screen used in the morning.
This hydroquinone screen cream contains hydroquinone in the
range of 0.1% to 2%, preferably 2% as a skin bleach in a
non-comedogenic water based emulsion. Also provided in the
hydroquinone screen cream is a broad spectrum [UVA and UVB]
sunscreen and emollients and moisturizers .
5. Sun protector is applied in the morning for day
time use via quick absorbing, oil-free emulsion for
sensitive skin. Broad spectrum [UVA and UVB] protection is
provided without the use of oxybenzone, lanolins, glycols,
etc. The UV filters are Octyl Methoxycinnamate in the range
of 1.5% to 7.5%, preferably 7.5% and Menthyl Anthranilate
WO 94/27569 PCT/US94/06443
~~6.4229
42
in the range of 1% to 10% and the oil-free emulsion itself
is a water-based emulsion comprised of a water-based
vehicle and an ester-based emollient phase.
Composite Skin - Therapy Phase
1. Cleansing twice daily is provided by the soap-free
cleanser during the maintenance phase. Cleansing is
accomplished with a soap-free cleansing lotion as in the
therapy phase, the cleanser being designed to cleanse
efficiently without excessive drying or irritation of the
skin.
2. The degreaser is applied twice daily to deep clean
the skin and remove excess sebum, which may reduce the
effectiveness of the treatment pads. The degreaser is
applied in the morning only to the areas of T-zone
oiliness. The degreaser is a hydro-alcoholic solution
containing acetone in the concentration range of 0.1% to
10% but preferably 5% .
3. 15-2-2 Treatment Pads contain the
peeling/exfoliating agent combination glycolic acid
[preferably 15%, but over the possible range of 1-20%],
salicylic acid [preferably 2%, but over the possible range
of 0.1% to 5%], and lactic acid [preferable 2%, but over a
possible range of 0.1% to 20%]. The peeling/exfoliating
agent combination is provided in a penetrating hydro-
alcoholic vehicle containing acetone as a co-solvent to
insure proper delivery of the peeling/exfoliating agent to
the skin area to be treated. The 15-2-2 combination works
synergistically with acetone as a peeling agent [preferably
5% but over the possible range of 0.1% to 10%]. See Tables
1 and 2 for compositions and concentration ranges.
4. After the peeling/exfoliating treatment, the
therapeutic hydrocortisone balm is applied, containing the
well-known anti-inflammatory and anti-pruritic drug
hydrocortisone in the concentration range 0.1% to 2.5%,
preferably 1% in a hydrous base.
5. Moisturizer and UV protection is applied via quick
absorbing, oil-free emulsion for UV protection of
combination skin during the day time, and is applied in the
WO 94/27569 ~ 16 41229 PCT/US94/06443
43
morning after cleansing. Broad spectrum [UVA and UVB]
protection is provided without the use of oxybenzone,
lanolins, glycols, etc. The UV filters are Octyl
Methoxycinnamate in the range of 1.5% to 7.5% and Menthyl
Anthranilate in the range of 1% to 10%.
Composite Skin - Maintenance Phase
1. Cleansing twice daily is provided by the soap-free
cleanser during the maintenance phase. Cleansing is
accomplished with a soap-free cleansing lotion as in the
therapy phase, the cleanser being designed to cleanse
efficiently without excessive drying or irritation of the
skin.
2. The degreaser is applied twice daily to deep clean
the skin and remove excess sebum, which may reduce the
effectiveness of the treatment pads. The degreaser is
applied in the morning only to the areas of T-zone oiliness
and in the evening to the entire face or other skin area to
be treated. The degreaser is a hydro-alcoholic solution
containing acetone in the concentration range of 0.1% to
10% but preferably 5%
3. Gentle twice daily peeling/exfoliation is
accomplished by the use of the 5-2-2 treatment pad during
the maintenance phase. The 5-2-2 pad contains glycolic
acid [preferably 5%, but over a possible range of 1-20%],
salicylic acid [preferably 2%, but over a possible range of
0.1% to 5%], and lactic acid [preferably 2%, but over a
possible range of 0.1% to 20%]. The peeling/exfoliating
agent combination is carried in a penetrating hydro-
alcoholic vehicle containing acetone in the concentration
range of 0.1% to 10% as a co-solvent to insure proper
delivery of the peeling/ exfoliating agent to the skin area
to be treated. The 5-2-2 combination works synergistically
with acetone as a peeling agent [preferably 5% but over the
possible range of 0.1% to 10%]. See Tables 1 and 2 for
compositions and concentration ranges.
4. After the peeling/exfoliating treatment, the
therapeutic balm is applied in the evening, containing the
well-known anti-inflammatory and anti-pruritic drug
WO 94/27569 PCT/US94/06443
22
44
hydrocortisone in the concentration range 0.1% to 2.5%,
preferably 1% in a hydrous base.
5. Sun protector is applied in the morning for day
time use via quick absorbing, oil-free emulsion for
sensitive skin. Broad spectrum [UVA and UVB] protection is
provided without the use of oxybenzone, lanolins, glycols,
etc. The UV filters are Octyl Methoxycinnamate in the
range of 1.5% to 7.5% and Menthyl Anthranilate in the range
of 1% to 10% and the oil-free emulsion itself is a water-
based emulsion comprised of a water-based vehicle and an
ester-based emollient phase.
In summary, the present invention provides a novel
home skin peel composition, method and kit for producing
healthy and attractive skin.
Other modifications may be made to the present
invention, without departing from the spirit and scope of
the present invention, as noted in the appended claims.
