Note: Descriptions are shown in the official language in which they were submitted.
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ANTIFUNGAL NAIL COMPOSITION AND METHOD OF USE
TECHNICAL FIELD OF THE INVENTION
This invention relates to a composition for treating fungal-infected human
nails.
BACKGROUND
Nail fungal infections (also known as onychomycosis, tinea unguium, or
ringworm of the nail; hereinafter referred to as "onychomycosis") are caused
by a fungal
invasion of the keratinous structure of a fingernail or toe nail by a variety
of fungi
including T~ychophyton sp., Microspo~um sp., Epidermaphyton sp.; Cavcdida sp.,
Ti~ichospo~o~ sp., Geotrichum sp., Scopula~iopsis sp., Aspergillus sp.,
Ac~emohium sp.,
Fusa~ium sp., Phyllosticta sp., Hendersonula sp., and Cheatomium sp. A fungal
infected
nail typically has a yellowish color that starts at one corner of the nail and
spreads
towards the cuticle. Over time, the infected nail presents as a thickened,
lusterless,
discolored nail, often with keratotic debris accumulated under the tip. Left
untreated, the
infected nail plate often becomes brittle, flaking, crumbling, friable,
striated, deformed,
separated, or completely destroyed. While onychomycosis is generally not
painful, the
unsightly appearance of the infected nail can be a source of embarrassment for
most
patients. For diabetics or immunosuppressed patients, an infected nail left
untreated can
result in severe infection.
Various systemic and topical preparations have been used to treat
onychomycosis.
Generally, the course of treatment is long-term and accompanied by a high
relapse rate.
Itraconazole, which inhibits the cytochrome P-450-dependent synthesis of
erosterol, a
vital component of fungal cell membranes, is available for oral
administration. The
recommended course of treatment with itraconazole for an infected toe nail is
twelve
weeks. For an infected fingernail, two one-week pulses of orally administered
itraconazole separated by three weeks is recommended. Griseofulvin is an oral
preparation that binds newly formed keratin, thus making new nail tissue
resistant to
fungal infection. Recommended treatment involves trimming away infected nail
tissue as
the nail grows out and requires at Ieast four months of treatment for an
infected fingernail
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2
and at least 6 months for an infected toe nail. Because griseofulvin is
derived from
Penicillium, the possibility of cross-sensitivity with penicillin exists,
limiting its use to
individuals not allergic to penicillins. Terbinafine hydrochloride is an oral
preparation
that prevents fungal growth by inhibiting squalene epoxidase and blocking
fungal cell
membrane synthesis. Recommended treatment of terbinafine hydrochloride is six
weeks
for an infected fingernail and 12 weeks for an infected toe nail. Topical
antifungal agents
include imidazoles or triazoles such as clotrimazole and ketoconazole,
ciclopirox,
amphotericin-B, gentian violet, resorcinol, and iodine. Despite the current
availability of
antifungal agents for treating onychomycosis, new compositions that axe less
expensive
to administer with a minimal relapse rate are desired.
The antifungal use of various copper salts is well known in the area of
agriculture
and aquaculture. For example, copper sulfate, copper carbonate, copper
oxychloride,
copper ammonium complex, copper oxide, copper hydroxide, copper naphthenates,
and
copper quinolinates have all been reported as effective fungicidal agents. The
antifungal
properties of copper sulfate solutions have been known for over 230 years and
were
utilized to eliminate wheat bunt (Tilletia sp.) and potato blight, the cause
of the Irish
Potato Famine. The oldest of the treatments to prevent the growth of
Phytophthora
i~cfestahs, the causative agent in potato blight, axe known as the Bordeaux
mixture and the
Burgundy mixture. Both solutions axe prepared for spraying on potato plants to
prevent
blight according to a rigorous schedule synchronized to the fungus lifecycle.
A 2%
Bordeaux mixture is most commonly used for potatoes and consists of a 2:1
mixture of
copper sulfate and hydrated lime in 100 gallons of water. A 1% Burgundy
mixture
consists of a 4:5 mixture of copper sulfate and sodium bicarbonate in 40
gallons of water.
Despite the availability of synthetic antifungal agents to prevent potato
blight, organic
farmers still utilize the Bordeaux mixture and the Burgundy mixture because
they are
safe, inexpensive, and easy to use.
In U.S. Patent No. 4,822,595 issued April 18, 1989, Corliss, et aI. disclose a
hoof
lotion that contains linseed oil as a dispersing agent, lanolin as a
moisturizer, turpentine
as a drying agent, iodine as an antiseptic agent, pine tar as a sticking
agent, hydrogen
peroxide as an antibacterial agent and copper sulfate as a fungicidal agent.
Copper
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3
sulfate is 0.53% by weight of the hoof lotion. Corliss, et al. described the
utility of the
claimed hoof lotion as killing and preventing fungal growths and healing
cracks, brittle
surfaces and hoof dryness.
Undecylenic acid as well as its copper, calcium and zinc salts and
combinations
thereof have been reported as antifungal agents for use in the treatment of
athlete's foot
(tines pedis). However, the foot creams, sprays, and ointments containing
undecylenates
have been limited to the treatment of skin fungal infections and specifically
disclaimed as
treatment for fungal nail infections.
A method for treating human onychomycosis has now been found comprising
contacting fungal infected human nails with copper salts, preferably copper
sulfate.
SUMMARY OF THE INVENTION
In one aspect, the invention is a nail composition comprising an effective
antifungal amount of a copper salt effective for arresting fungal invasion in
human nail
tissue. Exemplary copper salts useful in the composition of the present
invention include
copper acetates, copper ammonium complexes, copper carbonates, copper
perchlorates,
copper halides, copper gluconates, copper oxyhalides, copper lactates, copper
naphthenates, copper oxides, copper quinolinates copper salicylates, copper
selenates,
copper sulfates, and copper tartrates. Preferably, the copper salt is
copper(II)sulfate. The
composition preferably comprises from 1% (weight/weight) to 32%
(weight/weight)
aqueous copper(II)sulfate; more preferably, 10% (weight/weight) aqueous
copper(II)sulfate. Preferably, the composition is selected from the group
consisting of a
nail polish, acrylic nail product, gel nail product, cuticle softening
solution, nail
conditioning formulation, artificial nail product, and nail ornamental
product. In one
embodiment, the composition is a nail polish. In another embodiment, the nail
composition further comprises a fixative. In another embodiment, the nail
composition
further comprises an adhesive. In one embodiment, the composition is a cuticle
softening
solution. The composition can also release the copper salt over time using a
controlled-
release formulation.
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In one aspect, the invention is a nail composition comprising an effective
antifungal amount of a copper salt effective for arresting fungal growth on
human nail
tissue. Exemplary copper salts useful in the composition of the present
invention include
copper acetates, copper ammonium complexes, copper carbonates, copper
perchlorates,
copper halides, copper gluconates, copper oxyhalides, copper lactates, copper
naphthenates, copper oxides, copper quinolinates copper salicylates, copper
selenates,
copper sulfates, and copper tartrates. Preferably, the copper salt is
copper(II)sulfate. The
composition preferably comprises from 1% (weight/weight) to 32%
(weight/weight)
aqueous copper(II)sulfate; more preferably, 10% (weight/weight) aqueous
copper(II)sulfate. Preferably, the composition is selected from the group
consisting of a
nail polish, acrylic nail product, gel nail product, cuticle softening
solution, nail
conditioning formulation, artificial nail product, and nail ornamental
product. In one
embodiment, the composition is a nail polish. In another embodiment, the nail
composition further comprises a fixative. In another embodiment, the nail
composition
further comprises an adhesive. In one embodiment, the composition is a cuticle
softening
or nail conditioning solution. The composition can also release the copper
salt over time
using a controlled-release formulation.
In another aspect, the present invention is use of a copper salt in the
manufacture
of an antifungal nail medicament comprising an effective antifungal amount of
said
copper salt effective for arresting fungal invasion in human nail tissue.
In another aspect, the present invention is use of a copper salt in the
manufacture
of an antifungal nail medicament comprising an effective antifungal amount of
said
copper salt effective for arresting fungal growth on human nail tissue.
In another aspect, the present invention is use of a copper salt in the
manufacture
of a medicament for detecting fungal infection in a human nail comprising an
effective
antifungal amount of said copper salt to stain fungal infected human nail
tissue
In another aspect, the present invention is use of a copper salt in the
manufacture
of a medicament for preventing fungal infection in a healthy human nail
comprising an
effective antifungal amount of said copper salt.
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In another aspect, the present invention is use of a copper salt in the
manufacture
of a medicament for preventing fungal growth on a healthy human nail
comprising an
effective antifungal amount of said copper salt.
In another aspect, the invention is a method for treating a fungal infection
of a
5 human nail comprising topically applying an effective antifungal amount of a
composition comprising a copper salt to the nail, wherein the effective amount
arrests
fungal invasion of nail tissue. Preferably, the method utilizes one or more of
the nail
compositions disclosed herein.
In another aspect, the invention is a method for treating a fungal growth on a
human nail comprising topically applying an effective antifungal amount of a
composition comprising a copper salt to the nail, wherein the effective amount
arrests
fungal growth. Preferably, the method utilizes one or more of the nail
compositions
disclosed herein.
In another aspect, the invention is a method for persistent treatment of a
fungal
infection of a human nail comprising topically applying an effective
antifungal amount of
a composition comprising a copper salt to the nail, wherein the effective
amount capable
of arresting fungal invasion of nail tissue persists on the fungal infected
nail tissue after
repeated washing of the nail with a suitable solvent. Preferably, the method
utilizes one
or more of the nail compositions disclosed herein.
In another aspect, the invention is a method of detecting fungal infection in
a
human nail comprising topically applying an effective amount of a composition
comprising a copper salt to the infected nail, wherein the composition visibly
stains any
fungal infected nail tissue; washing the infected nail with a suitable solvent
to remove
stain from uninfected nail tissue; and equating the persistent stained nail
tissue with
fungal infected nail tissue. Preferably, the method utilizes one or more of
the nail
compositions disclosed herein.
In another aspect, the invention is a method of monitoring fungal infection in
a
human nail comprising, at a first time point, topically applying an effective
amount of a
composition comprising a copper salt to the infected nail, wherein the
composition
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6
visibly stains any fungal infected nail tissue; washing the nail with a
suitable solvent to
remove stain from uninfected nail tissue; equating the persistent stained nail
tissue with
fungal infected nail tissue; comparing the area of persistent stained nail
tissue to the area
of unstained nail tissue; at a second time point, topically applying an
effective amount of
a composition comprising a copper salt to the nail, wherein the composition
stains any
fungal infected nail tissue; washing the nail with a suitable solvent to
remove stain from
uninfected nail tissue; equating the persistent stained nail tissue with
fungal infected nail
tissue; comparing the area of persistent stained nail tissue to the area of
unstained nail
tissue; wherein an increase in the area ratio of unstained nail tissue to
persistent stained
nail tissue at said second time point to the area ratio of unstained nail
tissue to persistent
stained nail tissue at said first time point indicates a decrease in fungal
infection.
Preferably, the method utilizes one or more of the nail compositions disclosed
herein.
In another aspect, the invention is a method of preventing fungal infection in
a
healthy human nail comprising topically applying an effective antifungal
amount of a
composition comprising a copper salt to the nail, wherein the composition
persists on the
healthy nail after repeated washing of the nail with a suitable solvent.
Preferably, the
method utilizes one or more of the nail compositions disclosed herein.
In another aspect, the invention is a method of preventing fungal growth on a
healthy human nail comprising topically applying an effective antifungal
amount of a
composition comprising a copper salt to the nail, wherein the composition
persists on the
healthy nail after repeated washing of the nail with a suitable solvent.
Preferably, the
method utilizes one or more of the nail compositions disclosed herein.
DETAILED DESCRIPTION
In one aspect, the present invention is a composition for treating human
onychomycosis comprising an effective antifungal amount of at least one copper
salt,
such as copper sulfate, which is safe for topical application to human nail
tissue and an
acceptable carrier. Upon application of the composition of the present
invention to
fungal infected human nail tissue, the fungal matter embedded in the infected
nail is
contacted with an effective antifungal amount of the copper salt(s). In one
embodiment
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7
of the present invention, it is advantageous that the composition of the
present invention
be reapplied to human nail tissue after an extended period of time. In another
embodiment, the composition of the present invention remains in contact with
the nail for
an extended period of time.
Exemplary copper salts include but are not limited to copper acetates, copper
ammonium complexes, copper carbonates, copper perchlorates, copper halides,
copper
gluconates, copper oxyhalides, copper lactates, copper naphthenates, copper
oxides,
copper quinolinates copper salicylates, copper selenates, copper sulfates, and
copper
tartrates can be used. Preferably, the copper salt is copper sulfate, also
known in the art
as copper sulfate, cupric sulfate, copper(II)sulfate, Roman vitriol, Fehling
solution A,
Salzburg vitriol, sulfuric acid copper(2+) salt, blue copper, copper
monosulfate, CuS04,
copper(2+)sulfate, cupric sulfate anhydrous, incracide E 51, blue stone, hi-
chef, blue
vitriol, natural chalcanthite, and other names. The most preferred form of
copper sulfate
utilized in the present invention is copper(II)sulfate pentahydrate. The
copper salts useful
in the present invention are commercially available from general chemical
suppliers such
as Sigma Chemical Company (St. Louis, MO), Aldrich (Milwaukee, WI), and
Mallinckrodt Laboratory Chemicals (Phillipsburg, NJ). It is understood that
the present
invention can utilize copper salts having a wide range of purity, including
but not limited
to industrial, technical, or reagent grade, provided that any impurity present
in the copper
salt is not harmful to humans on topical application.
For most uses, the composition of present invention preferably comprises an
amount of one or more copper salts equivalent to the amount of copper found in
a 1-32%
(weight/weight) aqueous composition of copper (II) sulfate at room
temperature.
However, practical concentrations can vary from trace amounts to a paste of
approximately 100% (weightlweight) of copper salts such as copper sulfate,
depending
upon the frequency of application, type of application, type of carrier used,
and toxicity
andlor patient sensitivity to the copper salt as disclosed herein. The
preferred
concentration of copper salts useful in the present invention can vary
depending upon the
type of application, wherein the concentration of copper salt in a composition
for the
treatment of fungal infection is preferably higher than the concentration of
copper salt
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used in nail polish or adhesive. Moreover, the preferred concentration of
copper salt
useful in the present invention for the treatment of fungal infection can vary
depending
upon the preferred treatment regimen. For example, a stronger concentration of
copper
salt is preferable in a composition which is infrequently applied; however,
for a patient
S having sensitivity to copper salt, a composition with a lower concentration
of copper salt
applied more frequently would be preferred. For the treatment of fungal
infection, a
preferred composition of the present invention comprises copper (II)sulfate at
a final
concentration of about 1%-32% (weight/weight); preferably, 7%-20%
(weight/weight);
most preferably, 10% (weight/weight) at room temperature.
An acceptable carrier useful in the composition of the present invention is
any
solvent system which stably solubilizes the copper salt and is tolerated by
human tissue.
An acceptable carrier must solubilize the copper salts) and prevent subsequent
recrystallization of the copper salts) over time. Any carrier suitable for the
active
ingredient of the current invention is herein considered part of this
application. The
1 S cosmetic arts are rich in chemicals suitable for applying to human skin
and nails. The
following compounds are merely examples and not meant to be limiting in any
way.
Carriers that may be used in conjunction with copper salts include
moisturizers such as
dimethicone silicone, isopropyl lanolate, lanolin, oleic acid, panthenal, and
stearic acid.
Surfactants or detergents such as sodium laureth sulfate can be added to the
copper salt
composition of the present invention to provide foaming, cleansing, wetting,
emulsifying,
solubilizing, and dispersing properties to the solution. Preservatives that
may be used in
a copper salt composition may include tocopherol and EDTA. Additionally,
antimicrobials such as parabens, quaternium-1 S, methylisothiazolinone, DMDM
hydantoin, and phenoxyethanol may also be used in a copper salt formulation.
It may be
2S advantageous to include thickeners, like microcrystalline waxes,
polyethylene thickeners,
and carbomer thickeners, in a copper salt composition. Solvents that may be
included in
a copper salt formulation include water, a combination of water and glycerol,
and a
combination of water and a volatile organic solvent(s), including but not
limited to
butylene and propylene glycol, cyclomethicone, and glycerin. Emulsifiers such
as
glyceryl monostearate, lauramide DEA, and polysorbates, may be advantageous to
add to
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a copper salt composition. To increase the penetration of the copper salt
composition
into the fungal infected nail, penetrating agents can optionally be added. It
is to be well
understood that any person skilled in the art could choose appropriate
surfactant,
penetrating, moisturizing, antimicrobial, and emulsifying agents if desired to
modify the
copper salt composition, all of which are contemplated by the present
invention.
For treatment of fungal infection, an effective antifungal amount of copper
salts)
can also be added to existing nail products such as a commercially available
nail polish
(e.g., REVLON, New York, New York; L'Oreal USA, Inc., New York, New York, and
CoverGirl, Procter & Gamble, Cincinnati, Ohio), acrylic nail products, gel
nail products,
cuticle softening solutions, nail conditioning preparations, or various
products used in
association with artificial nails or ornamentals. By adding a fixative, the
copper salt
composition can be applied as a semi-permanent film to the nails prior to the
application
of nail polish, artificial nails or ornamentals. Applying the composition of
the present
invention in a nail polish or as a film applied to the nails prior to the
application of nail
polish, artificial nails or ornamentals provides the advantage of having the
copper salt-
containing product remaining in contact with the nail for an extended period
of time.
Also, the nail polish can optionally comprise pigment when it is advantageous
to
minimize the appearance of staining of nail tissue caused by the copper salt:
It is
contemplated that one product or a combination of products comprising copper
salt in an
effective antifungal amount can be used.
The present invention is a method for treating onychomycosis in humans
comprising applying a copper salt composition, preferably with an absorbent
swab, felt,
gauze, eyedropper or brush, to the fungal infected nail. Preferably, the
copper salt
composition is applied for approximately 30 minutes and allowed to air dry. On
drying, a
powder coating of copper salt covers the treated skin and nail. On washing
with water or
other suitable solvent, the porous (infected) portion of the nail may be
permanently
stained from the copper salt, while normal nail tissue and skin is temporarily
stained and
returns to normal coloration. A suitable solvent for washing is any solvent
which is
capable of solubilizing the copper salt without causing damage to the nail
tissue or
surrounding skin. The washing solvent and the carrier in the copper salt
composition can
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be the same or different. For copper (II) sulfate, water is a preferred
solvent for washing.
Repeated washing of hands or feet over time generally results in further
migration of the
copper salt into the infected nail. Thus, normal washing does not interrupt
the treatment
process or require repeated application of the copper salt solution after each
washing. As
5 the treated nail grows, a narrow band having a reddish pink color may appear
immediately behind the blue-stained infected nail portion. As new, healthy
nail tissue
appears, the stained infected portion of the nail grows beyond the nail bed
and is trimmed
away. Application of the copper salt composition is repeated upon fading of
the stain,
more preferably at least once monthly until signs of infection are eliminated.
10 In addition to the copper salt treatment of the present invention, the
method to
treat onychomycosis in humans can include processes that are generally part of
nail
health maintenance including trimming and sanding the nail, keeping the nail
dry, and
treating the affected areas with chemicals to enhance the absorption of and/or
prevent the
leaching out of the copper salt from the nail over time. For example, clear or
colored nail
polish can be applied to the copper salt treated nail. Likewise, stained,
treated nails can
be cosmetically disguised by the application of colored nail polish.
Another aspect to the method of using a copper salt composition to treat human
onychomycosis includes treating nails before they present the symptoms of
onychomycosis. For example, if one toe nail exhibits the symptoms of
onychomycosis,
alI toe nails can be treated even if symptoms are not yet apparent.
Furthermore, since the
copper salt composition will stain only the nail portions exhibiting fungal
invasion, the
progress of the fungal infection within one nail can be monitored, or possible
spreading
to other nails can be detected. For example, a staining copper salt,
preferably copper
sulfate, can be added to routine soaking solutions used in the art prior to
manicuring or
pedicuring.
The copper salt composition of the present invention can also be used to
prevent
onychomycosis as well as the growth of noninvasive fungi residing on the
surface of
human nails, for example, fungi commonly seen in association with the use of
artificial
nails or ornamentals. In one aspect, a copper salt can be added to nail polish
formulations, acrylic nail products, gel nail products, cuticle softening
solutions, nail
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11
conditioning preparations, or various products used in association with
artificial nails or
ornamentals to effectively prevent the growth of fungi residing on the nail.
By adding a
fixative, the copper salt composition can be applied as a semi-permanent film
to the nails
prior to the application of nail polish, artificial nails or ornamentals.
Preferably, the
copper salt can be applied in a time-release formulation. It is contemplated
that one°
product or a combination of products comprising copper salt can be used in the
prevention of onychomycosis or superficial fungal growth.
Because of the potential staining properties of the copper salt composition of
the
present invention, containment of the copper salt composition during shipping
and
storage as well as upon application to infected nails is preferable. One
preferred method
is a waterproof paper, plastic or foil package containing an absorbent swab or
felt or
gauze pad saturated with copper salt composition, whereupon tearing away a
portion of
the package exposes the copper salt composition saturated absorbent tip of the
swab or a
portion of the copper salt composition saturated felt or gauze pad which can
be directly
applied to the infected nail. In another preferred method, the copper salt
composition is
encapsulated in a breakable ampule, the breakable ampule is enclosed in a
plyable
container capable of confining the ampule upon breakage and having one sealed
end and
one opened end that is packed with an absorbent material, and the whole device
is
enclosed in a waterproof paper, plastic or foil package. On use, the ampule is
broken to
release the copper salt composition, the absorbent material is saturated with
the copper
salt composition, a portion of the package is torn away to expose the copper
salt
composition saturated absorbent material which can be directly applied to the
infected
nail.
Example 1: Toe Nail Treatment
A male patient diagnosed as having a fungal infected toe nail, began treatment
by
applying an aqueous 10% (w/v) copper(II)sulfate pentahydrate solution to the
infected
nail using a copper sulfate saturated gauze pad. The copper sulfate solution
was applied
to the infected toe nail for approximately thirty minutes and then allowed to
air dry.
Excess copper sulfate powder was removed by washing two times with water. The
infected portion of the patient's nail had a bluish color. As the treated nail
grew, healthy
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12
nail tissue appeared at the base of the nail bed while the infected portion of
the nail was
pushed off the nail bed and periodically trimmed away. ~ver time, the fungal
infection
did not spread to healthy nail tissue and the stained, treated portion of the
nail was
removed.
Example 2: Toe Nail Treatment
A male patient diagnosed as having a fungal infected toe nail began treatment
by
applying with a cotton swab an aqueous 10% (w/v) copper(II)sulfate
pentahydrate
solution to the infected nail as well as to all nails on the same foot. The
copper sulfate
solution was applied to lus toe nails for approximately thirty minutes and
then allowed to
air dry. Excess copper sulfate powder was removed by washing two-three times
with
water. The patient's infected nail had a bluish color where the infection was
present. All
other nails return to normal coloration, indicating that the fungal infection
had not spread
from the infected toe to neighboring toe nails on the same foot. As the
treated nail grew,
healthy nail tissue appeared at the base of the nail bed while the infected
portion of the
nail was pushed off the nail bed and periodically trimmed away. Monthly, the
copper
sulfate solution was applied as given above to the infected nail and to all
nails on the
same foot. The infected portion of the patient's nail continued to have a
bluish color. All
other nails returned to normal coloration on washing, indicating that the
fungal infection
still had not spread from the infected toe to neighboring toe nails on the
same foot. Over
time, the fungal infection did not spread to healthy nail tissue and the
stained, treated
portion of the nail was removed, resulting in a normal healthy nail.
Example 3: Fingernail Treatment
A female patient diagnosed as having a fungal infected fingernail began
treatment
by applying with a cotton swab an aqueous 10% (w/v) copper(II)sulfate
pentahydrate
solution to the infected nail as well as to all nails on the same hand. The
copper sulfate
solution was applied to her fingernails for approximately thirty minutes and
then allowed
to air dry. Excess copper sulfate powder was removed by washing two-three
times with
water. The patient's infected nail had a bluish color where the infection was
present. All
other nails returned to normal coloration, indicating that the fungal
infection had not
spread from the infected fingernail to neighboring fingernails on the same
hand. The
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13
patient routinely covered her fingernails in an opaque, colored nail enamel
which
completely disguised the infected nail. As the treated nail grew, healthy nail
tissue
appeared at the base of the nail bed while the infected portion of the nail
was pushed off
the nail bed and periodically trimmed away. Monthly, the copper sulfate
solution was
applied as given above to the infected fingernail and to all fingernails on
the same hand.
The infected portion of the patient's nail continued to have a bluish color.
All other nails
returned to normal coloration on washing, indicating that the fungal infection
still had not
spread from the infected fingernail to neighboring fingernails on the same
hand. Over
time, the fungal infection did not spread to healthy nail tissue and the
stained, treated
portion of the nail was removed, resulting in a normal healthy nail.
Example 4: Fingernail Treatment
A female, 30 years old, was diagnosed as having an infection of onychomycosis
of the right index fingernail. The nail was separating from the nail bed along
the right
side of the nail and along the cuticle, leaving the nail hinged along the left
side of the nail
only. The patient required a bandage to prevent the nail from tearing free.
The right side
of the nail displayed the characteristic yellowing and rough, tluck texture
associated with
the fungal infection. Prior to the first treatment on Day 1, all fingernail
polish was
removed from the nail using over-the-counter nail polish remover. A bandage
was
soaked with a preparation consisting of a 10% aqueous copper sulfate solution
with a
trace of detergent added to act as a surfactant. The bandage was applied to
the infected
nail and secured in place. Care was given to ensure that the solution soaked
into the
crevice along the edge of the nail bed and cuticle. Subsequent hand washing
provided
additional wetting which drove more of the copper sulfate solution into the
nail bed and
surrounding crevice. The bandage was worn for two days and then replaced with
a clean
dry bandage to protect the nail from snagging. The treatment was repeated on
Day 31
and again on Day 45; no further treatments were given. Between treatments, the
patient
was permitted to resume the use of fingernail polish between treatments. On
Day 132,
the nail was examined. The patient was no longer wearing a dry bandage to
protect the
nail. New pink nail growth was present from the cuticle to a point midway
along the nail.
The new portion of the nail was attached normally on both sides of the nail
from the
CA 02431651 2003-06-16
WO 02/39963 PCT/USO1/29438
14
cuticle to the midpoint. There was a slight "keloid type" ridge across the
nail at the
midpoint. The old fungal infected nail was still separated from the midpoint
of the right
side of the nail to the end of the nail. The new growth immediately behind the
"keloid
type" ridge was rough in texture, typical of nail regrowth following a fungal
infection.
However, the nail newly emerging from the cuticle was smoother, like an
uninfected nail.
It is to be understood that the above description is of preferred exemplary
embodiments of the invention and is intended to be illustrative of the
invention, but is not
to be construed to limit the scope of the invention in any way. Modifications
may be
made in the composition features of the invention without departing from the
scope of the
invention. It will be readily apparent to those skilled in the art that
alternative materials
may also be utilized without departing from the scope of the invention.
