U.S. patent application number 11/031172 was filed with the patent office on 2005-07-07 for cosmetic composition and method for retarding hair growth.
Invention is credited to Chen, Chia Wen, Fthenakis, Christina G., Goldstein, Mindy S., Marenus, Kenneth D..
Application Number | 20050147631 11/031172 |
Document ID | / |
Family ID | 34794343 |
Filed Date | 2005-07-07 |
United States Patent
Application |
20050147631 |
Kind Code |
A1 |
Goldstein, Mindy S. ; et
al. |
July 7, 2005 |
Cosmetic composition and method for retarding hair growth
Abstract
The present invention comprises cosmetic compositions and
methods for retarding hair growth comprising a combination of an
ornithine decarboxylase inhibitor, an anti-angiogenic active and an
anti-inflammatory.
Inventors: |
Goldstein, Mindy S.;
(Plainview, NY) ; Chen, Chia Wen; (Bronxville,
NY) ; Fthenakis, Christina G.; (Dix Hills, NY)
; Marenus, Kenneth D.; (Dix Hills, NY) |
Correspondence
Address: |
Karen A. Lowney, Esq.
ESTEE LAUDER COMPANIES
Ste. 345 South
155 Pinelawn Road
Melville
NY
11747
US
|
Family ID: |
34794343 |
Appl. No.: |
11/031172 |
Filed: |
January 7, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60535125 |
Jan 7, 2004 |
|
|
|
Current U.S.
Class: |
424/401 ;
424/195.16; 424/729; 424/757; 424/769; 514/27; 514/456; 514/559;
514/78 |
Current CPC
Class: |
A61K 8/9789 20170801;
A61K 8/35 20130101; A61K 8/63 20130101; A61K 8/68 20130101; A61K
31/7048 20130101; A61K 31/685 20130101; A61K 8/987 20130101; A61K
31/375 20130101; A61Q 7/02 20130101; A61K 31/20 20130101; A61K
8/9728 20170801; A61K 2800/782 20130101; A61K 45/06 20130101; A61K
31/20 20130101; A61K 2300/00 20130101; A61K 31/375 20130101; A61K
2300/00 20130101; A61K 31/685 20130101; A61K 2300/00 20130101; A61K
31/7048 20130101; A61K 2300/00 20130101 |
Class at
Publication: |
424/401 ;
424/757; 514/078; 514/559; 424/769; 424/195.16; 424/729; 514/027;
514/456 |
International
Class: |
A61K 035/72; A61K
031/7048; A61K 031/375; A61K 031/20; A61K 031/685 |
Claims
What is claimed is:
1. A cosmetic composition comprising: an ornithine decarboxylase
inhibitor; an anti-angiogenic active; an anti-inflammatory; and a
cosmetically acceptable vehicle.
2. The cosmetic composition of claim 1 wherein the ornithine
decarboxylace inhibitor is a pentacyclic triterpene selected from
the group consisting of ursolic acid, betulin, betulinic acid,
oleanolic acid, betulin mono and di-succinate or glutarate and
polyethylene glycol and wherein the ornithine decarboxylace
inhibitor is present in an amount from 0.1% to 50%.
3. The cosmetic composition of claim 1 wherein the anti-angiogenic
active is a sphingo lipid selected from the group consisting of
phytosphingosine, dihydrosphingosine, sphingosine and
dehydrosphingosine and wherein the anti-angiogenic active is
present in an amount of from 0.01% to 10%.
4. The cosmetic composition of claim 1 wherein the anti-angiogenic
active is selected from the group consisting of magnolia extract,
shark cartilage and tetrahydrocurcumin.
5. The cosmetic composition of claim 1 wherein the
anti-inflammatory is selected from the group consisting of
gorgonian extract, hoelen extract, ximenynic acid, hesperitin, tea
polyphenols and licorice extract and wherein the anti-inflammatory
is present in an amount from 0.0001% to 20%.
6. The cosmetic composition of claim 1 further comprising a
whitening agent selected from the group consisting of yeast
extract, ferulic acid, vitamin C derivatives, Na+ hinokitiol,
licorice extract, extracts of mitracarpus scaber/bearberry,
extracts of mulberry/scutellaria, arbutin, resveratrol and kojic
acid.
7. The cosmetic composition of claim 1 further comprising a plant
extract selected from the list consisting of soy extract, wild yarn
and ginseng.
8. The cosmetic composition of claim 1 further comprising a 5 alpha
reductase inhibitor selected from the group consisting of saw
palmetto, woodworm (Artemisinin), liposome encapsulated azuleic
acid (Azelosome), clove extract (Chouji Liquid), Zinc salt of
L-Pyrrolidone Carboxylic Acid (Zincidoneg), mixture of water,
hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodium
chondroitin sulfate (Capigen), seaweed extract (Phlorogine),
isolutrol, progesterone, (5,20-R)-4-diazo-21-hydroxy-20-met- hyl
pregnan-3-one, (4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,
4-androstene-3-one-17-carboxylic acid, and its methyl ester,
17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,
11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and
20-alpha-OH-progesterone.
9. A cosmetic composition comprising: from 0.1 to 50% of a
penticylic triterpene; from 0.01 to 10% of a sphingo lipid; from
0.0001 to 20% of gorgonian extract; and a cosmetically acceptable
vehicle.
10. The cosmetic composition of claim 9 wherein the pentacyclic
triterpene is selected from the group consisting of ursolic acid,
betulin, betulinic acid, oleanolic acid, betulin mono and
di-succinate or glutarate and polyethylene glycol.
11. The cosmetic composition of claim 9 wherein the sphingo lipid
is selected from the group consisting of phytosphingosine,
dihydrosphingosine, sphingosine and dehydrosphingosine.
12. The cosmetic composition of claim 9 further comprising an
anti-angiogenic active selected from the group consisting of
magnolia extract, shark cartilage and tetrahydrocurcumin.
13. The cosmetic composition of claim 9 further comprising a
whitening agent selected from the group consisting of yeast
extract, ferulic acid, vitamin C derivatives, Na+ hinokitiol,
licorice extract, extracts of mitracarpus scaber/bearberry,
extracts of mulberry/scutellaria, arbutin, resveratrol and kojic
acid.
14. The cosmetic composition of claim 9 further comprising a plant
extract selected from the group consisting of soy extract, wild
yarn, and ginseng.
15. The cosmetic composition of claim 9 further comprising a 5
alpha reductase inhibitor selected from the group consisting of saw
palmetto, woodworm (Artemisinin), liposome encapsulated azuleic
acid (Azelosome), clove extract (Chouji Liquid), Zinc salt of
L-Pyrrolidone Carboxylic Acid (Zincidone.RTM.), mixture of water,
hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodium
chondroitin sulfate (Capigen), seaweed extract (Phlorogine),
isolutrol, progesterone, (5,20-R)-4-diazo-21-hydroxy-20-methyl
pregnan-3-one, (4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,
4-androstene-3-one-17-carboxylic acid, and its methyl ester,
17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,
11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and
20-alpha-OH-progesterone.
16. A method for retarding the growth hair comprising applying a
composition comprising from 0.1 to 50% of an ornithine
decarboxylase inhibitor; from 0.01 to 10% of an anti-angiogenic
active; from 0.0001 to 20% of an anti-inflammatory; and a
cosmetically acceptable vehicle.
17. The method of claim 16 wherein the ornithine decarboylace
inhibitor is a pentacyclic triterpene selected from the group
consisting of ursolic acid, betulin, betulinic acid, oleanolic
acid, betulin mono and di-succinate or glutarate and polyethylene
glycol.
18. The method of claim 16 wherein the anti-angiogenic active is a
sphingo lipid selected from the group consisting of
phytosphingosine, dihydrosphingosine, sphingosine and
dehydrosphingosine.
19. The method of claim 16 wherein the anti-angiogenic active is
selected from the group consisting of magnolia extract, shark
cartilage and tetrahydrocurcumin.
20. The method of claim 16 wherein the anti-inflammatory is
selected from the group consisting of gorgonian extract, hoelen
extract, ximenynic acid, hesperitin, tea polyphenols and licorice
extract.
21. The method of claim 16 wherein the composition further
comprises a whitening agent selected from the group consisting of
yeast extract, ferulic acid, vitamin C derivatives, Na+ hinokitol,
licorice extract, extracts of mitracarpus scaber/bearberry, extract
of mulberry/scutellaria, arbutin, resveratrol and kojic acid.
22. The method of claim 16 wherein the composition further
comprises a plant extract selected from the group consisting of soy
extract, wild yarn and ginseng.
23. The method of claim 16 wherein the composition further
comprises a 5 alpha reductase inhibitor selected from the group
consisting of saw palmetto, woodworm (Artemisinin), liposome
encapsulated azuleic acid (Azelosome), clove extract (Chouji
Liquid), Zinc salt of L-Pyrrolidone Carboxylic Acid
(Zincidone.RTM.), mixture of water, hydrolyzed soy protein,
3-aminopropane, sulfonic acid and sodium chondroitin sulfate
(Capigen), seaweed extract (Phlorogine), isolutrol, progesterone,
(5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,
(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,
4-androstene-3-one-17-carboxylic acid, and its methyl ester,
17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,
11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and
20-alpha-OH-progesterone.
24. A method of retarding hair growth comprising applying a
cosmetic composition comprising: from 0.1 to 50% of a penticylic
triterpene; from 0.01 to 10% of a sphingo lipid; from 0.0001 to 20%
of gorgonian extract; and a cosmetically acceptable vehicle.
25. The method of claim 24 wherein the pentacyclic triterpene is
selected from the group consisting of ursolic acid, betulin,
betulinic acid, oleanolic acid, betulin mono and di-succinate or
glutarate and polyethylene glycol.
26. The method of claim 24 wherein the sphingo lipid is selected
from the group consisting of phytosphingosine, dihydrosphingosine,
sphingosine and dehydrosphingosine.
27. The method of claim 24 wherein the composition further
comprises an anti-angiogenic active selected from the group
consisting of magnolia extract, shark cartilage and
tetrahydrocurcumin.
28. The method of claim 24 wherein the composition further
comprises a whitening agent selected from the group consisting of
yeast extract, ferulic acid, vitamin C derivatives, Na+ hinokitol,
licorice extract, extracts of mitracarpus scaber/bearberry, extract
of mulberry/scutellaria, arbutin, resveratrol and kojic acid.
29. The method of claim 24 wherein the composition further
comprises a plant extract selected from the group consisting of soy
extract, wild yarn, and ginseng.
30. The method of claim 24 wherein the composition further
comprises a 5 alpha reductase inhibitor selected from the group
consisting of saw palmetto, woodworm (Artemisinin), liposome
encapsulated azuleic acid (Azelosome), clove extract (Chouji
Liquid), Zinc salt of L-Pyrrolidone Carboxylic Acid
(Zincidone.RTM.), mixture of water, hydrolyzed soy protein,
3-aminopropane, sulfonic acid and sodium chondroitin sulfate
(Capigen), seaweed extract (Phlorogine), isolutrol, progesterone,
(5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,
(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,
4-androstene-3-one-17-carboxylic acid, and its methyl ester,
17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,
11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and
20-alpha-OH-progesterone.
Description
[0001] This application claims priority of U.S. provisional
application 60/535,125 filed Jan. 7, 2004.
FIELD OF THE INVENTION
[0002] The present invention relates to skin care cosmetic
compositions and methods. In particular, the present invention
relates to novel cosmetic compositions and methods for retarding
hair growth.
BACKGROUND OF THE INVENTION
[0003] For years, companies have marketed products for either hair
growth or hair growth retardation, with limited success. From
mechanical procedures to compositions containing biologically
active ingredients, numerous means are available for the consumer.
Use of hair dyes to color hair, require frequent repetitions and
are not often effective in hiding the appearance of hair on the
skin.
[0004] Especially in suppressing hair growth, the prior art has
taught the use of numerous actives including biological enzymes,
plant extracts and enzyme inhibitors. For example, U.S. Pat. No.
6,375,948 teaches the use of an extract of a plant of the family
Juniperus or a malt, an elastase inhibitor or neutral endopeptidase
inhibitor and a proteolytic enzyme to suppress hair growth. In U.S.
Pat. No. 6,407,056, the patent teaches a method of delaying
mammalian hair growth comprising topically applying an effective
amount of a composition comprising a serine protease and a
pharmaceutically or cosmetically acceptable vehicle.
[0005] The references discussed above have limited and only short
term usefulness. Other references turn to the factors that are
believed to contribute to hair growth to develop formulas for
regulating hair growth.
[0006] For example, angiogenesis is the fundamental process by
which new blood vessels are formed. The process involves the
migration of vascular endothelial cells into tissue, followed by
the condensation of such endothelial cells into vessels.
Angiogenesis involves a complex interplay of molecules that
stimulate and molecules that inhibit the growth and migration of
endothelial cells. In U.S. Pat. No. 6,391,850, it was found that an
anti-angiogenic, SLED, stimulated the growth of hair. It was
believed that SLED affected hair growth by mediating angiogenesis
within the hair follicle.
[0007] Sphingo Glycolipids, such as phytosphingosine (known to be
an anti-angiogenic), have been used in skin care compositions to
aid in hair growth. For example, U.S. Pat. No. 5,565,207 ("patent
'207") teaches the use of a scalp moisturizer comprising a steroid
glycoside and/or a triterpenoid glycoside, a sphingo glycolipid and
a follicular hormone and/or an adrenocortical hormone. Patent '207
recognizes the use of the scalp moisturizer to stimulate hair
growth.
[0008] It is important to note that the references discussed above
teach the use of anti-angiogenics to aid in promoting hair
growth.
[0009] Yet another factor believed to contribute to hair growth is
Ornithine Decarboxylase (OCD), an enzyme that catalyzes the
decarboxylation of ornithine to putrescine. The reaction is the
first step in the biosynthesis of the polyamides known as
spermidine and spermine. The polyamides are known to play an
important role in cell growth and proliferation. U.S. Pat. No.
4,720,489 ("patent '489") teaches the use of ornithine
decarboxylase inhibitors to retard hair growth. Patent '489
specifically teaches against the use of certain ornithine
decarboxylase inhibitors that can have secondary pharmacological
effects.
[0010] In summary, the references discussed above teach that
anti-angiogenic agents promote hair growth while certain ornithine
decarboxylase inhibitors retard hair growth. Still other references
teach compositions with only limited efficacy.
[0011] There still remains a need for a novel composition and
method for inhibiting hair growth that has prolonged efficacy that
can be accomplished preferably by manipulating the numerous factors
that contribute to hair growth.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1. Chart depicting results of Self Assessment of
product containing inventive composition of the present invention
from the Clinical Study in Example 1.
[0013] FIG. 2. Chart depicting results of product evaluation after
eight weeks of use from the Clinical Study in Example 1.
[0014] FIG. 3. Chart depicting results of image analysis of
clinical study in Example 1 using inventive composition of the
present invention.
[0015] FIG. 4. Chart depicting results of comparative study between
inventive composition and conventional hair growth retardation
product.
SUMMARY OF THE INVENTION
[0016] The present invention comprises a cosmetic composition
comprising from 0.1 to 50% of an ornithine decarboxylase inhibitor,
from 0.01 to 10% of an anti-angiogenic active, from 0.0001 to 20%
of an anti-inflammatory and a cosmetically acceptable vehicle.
[0017] The present invention further comprises a method of
retarding hair growth comprising applying a composition comprising
from 0.1 to 50% of an ornithine decarboxylase inhibitor, from 0.01
to 10% of an anti-angiogenic active, from 0.0001 to 20% of an
anti-inflammatory and a cosmetically acceptable vehicle.
DETAILED DESCRIPTION
[0018] Except in operating and comparative examples, or where
otherwise explicitly indicated, all numbers in this description
indicating amounts or ratios of material or conditions of reaction,
physical properties of materials and/or use are to be understood as
modified by the word "about." All amounts are by weight of the
final composition, unless otherwise specified.
[0019] It has been surprisingly discovered that the combination of
an ornithine decarboxylase inhibitor with an anti-angiogenic active
and an anti-inflammatory effectively suppresses hair growth.
[0020] In a preferred embodiment, the ornithine decarboxylase
inhibitor is derived from a marine, synthetic, or naturally derived
source as opposed to an animal derived source. Preferred inhibitors
are pentacyclic triterpenes. Examples of pentacyclic triterpenes
include ursolic acid, betulin, betulinic acid, oleanolic acid,
betulin mono and di-succinate or glutarate. Particularly preferred
is ursolic acid extracted from Rosmarinus officinalis, which is
commercially available from Sabinsa Corporation in 121 Ethel Road
West, Unit #6, Piscataway, N.J. 08854.
[0021] The amount will vary depending on the formulation and the
performance desired. The ornithine decarboxylase inhibitor is used
in an amount from 0.001% to 90% by weight of the composition is
used. Preferably, an amount of from 0.001% to 60% is used and most
preferably, an amount of from 0.01% to 3% is used.
[0022] The preferred composition further comprises an
anti-angiogenic active. Although anti-angiogenic agents have been
known to promote hair growth, it has been surprisingly found that
an anti-angiogenic can aid in the inhibition of hair growth in the
present inventive combination. Particularly preferred
anti-angiogenics include sphingo lipids. Examples of sphingo lipids
include phytosphingosine, dihydrosphingosine, sphingosine,
dehydrophytosphingosine, monohexosylceramide, sphingoplamalogen,
acetyl sphingosine and monohexaosylceramide fatty acid ester. Other
anti-angiogenic agents include magnolia extract, MDI complex (shark
cartilage) and tetrahydrocurcumin and extracts of green tea.
[0023] The amount will vary depending on the formulation and the
performance desired. In general, the anti-angiogenic is used in an
amount from 0.001% to 90% by weight of the composition is used.
Preferably, an amount of from 0.01% to 60% and most preferably, an
amount of from 0.1% to 2% is used.
[0024] Inflammation and related irritation can detrimentally
interfere with the ability of actives to penetrate the skin and
provide their intended benefit. Anti-inflammatories have been used
in hair growth compositions to enhance the activity of hair growth
promoting actives (See U.S. Pat. No. 6,451,777). However, in the
present invention, it has been surprisingly discovered that an
anti-inflammatory when combined with an ornithine decarboxylase
inhibitor and an anti-angiogenic agent actually aids in inhibiting
hair growth.
[0025] The anti-inflammatory used in the present invention can be
selected from any known in the art. A particularly preferred
anti-inflammatory is gorgonian extract. Gorgonian extract is a
marine-derived, natural extract available from the Lipo Chemical
Company, Patterson, N.J. as a liquid extract of Sea Whip,
pseudopterogorgia elisabethae, supplied as a 4% Sea Whip extact in
butylene glycol. The Caribbean Sea Whip pseudoptemgorgia
elisabethae has been reported in Proc. Natl. Acad. Sci. USA, Vol.
83, pp. 6238-6240 (September 1986) as containing pseudopterosins
which are diterpene-pentose glycosides. U.S. Pat. No. 4,849,410 and
U.S. Pat. No. 4,745,104, incorporated by reference herein, provide
further disclosure on the Caribbean gorgonians. Alternatively,
anti-inflammatories such as boswellin, hoelen extract, ximenynic
acid, hesperitin, tea polyphenols and licorice extract may be
used.
[0026] The amount will vary depending on the formulation and the
performance desired. Specifically, amounts of an anti-inflammatory
such as gorgonian extract for purposes of this invention will range
from 0.00001% to 20%, preferably from 0.0001% to 5%, and most
preferably from 0.1% to 1% by weight.
[0027] It has been surprisingly found that hair growth can be
significantly inhibited by addition of a 5 alpha reductase
inhibitor to the inventive combination. It is known that 5 alpha
reductase promotes the formation of 5 dihydrotestosterone (DHT), a
product of testosterone. DHT is the hormone in skin that stimulates
hirsutism, which is male pattern hair growth. It is believed that
reducing DHT can result in reduction of hirsutism or male pattern
hair loss. Therefore, inhibiting the formation of 5 alpha reductase
is believed to prevent the formation of DHT and therefore prevent
hirsutism and prevent male pattern hair loss. Surprisingly,
however, it is believed that combining a 5 alpha reductase
inhibitor with the presenting inventive composition helps retard
hair growth in all areas of the body, including areas with typical
male pattern hair loss, as shown in Example 3 below.
[0028] Suitable 5 alpha reductase inhibitors include inhibitors
commonly known in the art and include but are not limited to saw
palmetto, woodworm (Artemisinin), liposome encapsulated azuleic
acid (Azelosome), clove extract (Chouji Liquid), Zinc salt of
L-Pyrrolidone Carboxylic Acid (Zincidone.RTM.), mixture of water,
hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodium
chondroitin sulfate (Capigen), seaweed extract (Phlorogine),
isolutrol, progesterone, (5, 20-R)-4-diazo-21-hydroxy-20-methyl
pregnan-3-one, (4R)-5-10-seco-19-Norpr- egna4,5-diene-3,10,20
trione, 4-androstene-3-one-17-carboxylic acid, and its methyl
ester, 17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-and-
rostane-3-one, 11-alpha-OH-progesterone, 17-alpha-OH-progesterone,
and 20-alpha-OH-progesterone.
[0029] The amount will vary depending on the formulation and the
performance desired. Preferably, the 5 alpha reductase inhibitor is
saw palmetto and is present in the amount from 0.0001% to 10%, more
preferably from 0.001% to 5% and most preferable from 0.01% to
1%.
[0030] In yet another alternate preferred embodiment, the
appearance of hair can be further reduced by the addition of a
whitening agent in the inventive formulations. Suitable whitening
agents include yeast extract (Yeast AE), ferulic acid, BV-OSC
(vitamin C derivative from Barnet), Na+ hinokitiol, licorice
extract (glabridin), etioline (extract of mitracarpus &
bearberry in combination with glycerin and butylene glycol),
phytoclar II (mulberry & scutellaria from Coletica), arbutin,
resveratrol and kojic acid. Particularly preferred is glabridin
obtained from Alchem Internationl Ltd., at 201, Empire Plaza,
Mehrauli-Gurgaon Road, Sultanpur, New Delhi, India.
[0031] The amount will vary depending on the formulation and the
performance desired. Preferably, the whitening agent is present in
the amount from 0.0001% to 20%, more preferably from 0.001% to 15%
and most preferable from 0.01% to 10%.
[0032] It is believed that a component with estrogen-like activity
may surprisingly aid in compositions for the retardation of hair
growth. Therefore, in an alternate preferred embodiment, the
present invention further comprises an estrogen-like component.
Particularly preferred supplements are plant extracts such as
solgen-40 C (a soy extract), wild yarn and ginseng or
phytoestrogens derived therefrom. Particularly preferred is
solgen-40 C obtained from Solbar Hatzor Ltd. located in Kibbutz
Hatzor, P.O. Box 2230, Ashdod, Israel, 77121.
[0033] The amount will vary depending on the formulation and the
performance desired. Preferably, the plant extract is present in an
amount of 0.0001% to 25%, more preferably from 0.001% to 15% and
most preferably from 0.01% to 10%.
[0034] In yet another preferred embodiment, the present inventive
composition may contain conventional hair removal ingredients (such
as thioglycollate) in any amount desired as would be compatible
with the present composition. A list of conventional hair removal
ingredients can be found in the International Cosmetic Ingredient
Dictionary, CTFA, Sixth Edition, 1995.
[0035] The composition further comprises a cosmetically acceptable
vehicle that is suitable for topical application to skin, hair
and/or nails. Cosmetically acceptable vehicles are well known in
the art and are selected based on the end use of the application.
For example, vehicles of the present invention include, but are not
limited to, those suitable for application to the skin. Such
vehicles are well known to those of ordinary skill in the art, and
can include one or more compatible liquid or solid filler diluents
or vehicles which are suitable for application to the skin. The
exact amount of vehicle will depend upon the level of any other
optional ingredients that one of ordinary skill in the art would
classify as distinct from the vehicle (e.g., other active
components). The compositions of the present invention preferably
comprise from about 40% to about 99.99%, more preferably from about
70% to about 99.99%, and most preferably from about 80% to about
98%, by weight of the composition, of a vehicle.
[0036] The vehicle and the compositions herein can be formulated in
a number of ways, including but not limited to emulsions. For
example, suitable emulsions include oil-in-water, water-in-oil,
water-in-oil-in-water, oil-in-water-in-oil, and
oil-in-water-in-silicone emulsions. Preferred compositions comprise
an oil-in-water emulsion.
[0037] The compositions of the present invention can be formulated
into a wide variety of product types, including shampoos, creams,
waxes, pastes, lotions, milks, mousses, gels, oils, tonics and
sprays. Preferred compositions are formulated into lotions, creams,
gels, shampoos and sprays. These product forms may be used for a
number of applications, including but not limited to, hand and body
lotions, cold creams, facial moisturizers, anti-acne preparations,
topical analgesics, make-ups/cosmetics including foundations,
eyeshadows, lipsticks and the like. Any additional components
required to formulate such products vary with product type and can
be routinely chosen by one skilled in the art.
[0038] If compositions of the present invention are formulated as
an aerosol and applied to the skin as a spray-on product, a
propellant is added to the composition. Examples of suitable
propellants include chlorofluorinated lower molecular weight
hydrocarbons. A more complete disclosure of propellants useful
herein can be found in Sagarin, Cosmetics Science and Technology,
2nd Edition, Vol. 2, pp. 443-465 (1972).
[0039] Other Components
[0040] The formulation also can comprise other components that may
be chosen depending on the carrier and/or the intended use of the
formulation. Additional components include, but are not limited to,
water soluble sunscreens (such as Eusolex 232); oil soluble
sunscreens (such as octyl methoxycinnamate); and organic sunscreens
(such as camphor derivatives, cinnamates, salicylates,
benzophenones, triazines, PABA derivatives, diphenylacrylate
derivatives, and dibenzoylmethane derivatives.); antioxidants (such
as BHT); chelating agents (such as disodium EDTA); emulsion
stabilizers (such as carbomer); preservatives (such as methyl
paraben); fragrances (such as pinene); flavoring agents (such as
sorbitol); humectants (such as glycerine); waterproofing agents
(such as PVP/Eicosene copolymer); water soluble film-formers (such
as hydroxypropyl methylcellulose); oil-soluble film formers (such
as hydrogenated C-9 Resin); moisturizing agents, such as
cholesterol; cationic polymers (such as Polyquatenium 10); anionic
polymers (such as xanthan gum); vitamins (such as tocopherol); and
the like.
[0041] The compositions can also encompass one or more active
components, and as such can be either cosmetic or pharmaceutical
compositions. Examples of useful actives include, but are not
limited to, those that improve or eradicate age spots, keratoses
and wrinkles, analgesics, anesthetics, anti-acne agents,
antibacterials, antiyeast agents, antifungal agents, antiviral
agents, antidandruff agents, antidermatitis agents, antipruritic
agents, antiemetics, antihyperkeratolytic agents, anti-dry skin
agents, antiperspirants, antipsoriatic agents, antiseborrheic
agents, hair conditioners and hair treatment agents, antiaging
agents, antiwrinkle agents, antiasthmatic agents and
bronchodilators, sunscreen agents, antihistamine agents,
depigmenting agents, wound-healing agents, vitamins,
corticosteroids, tanning agents or hormones. More specific examples
of useful active agents include retinoids such as retinol, and
esters, acids, and aldehydes thereof; ascorbic acid, and esters and
metal salts thereof, tocopherol and esters and amide derivatives
thereof; shark cartilage; milk proteins; alpha- or beta-hydroxy
acids; DHEA and derivatives thereof; topical cardiovascular agents;
clotrimazole, ketoconazole, miconozole, griseofulvin, hydroxyzine,
diphenhydramine, pramoxine, lidocaine, procaine, mepivacaine,
monobenzone, erythromycin, tetracycline, clindamycin, meclocyline,
hydroquinone, minocycline, naproxen, ibuprofen, theophylline,
cromolyn, albuterol, hydrocortisone, hydrocortisone 21-acetate,
hydrocortisone 17-valerate, hydrocortisone 17-butyrate,
betamethasone valerate, betamethasone diproprionate, triaminolone
acetonide, fluocinonide, clobetasol, proprionate, benzoyl peroxide,
crotamiton, propranol, promethazine, and mixtures thereof.
[0042] Particularly preferred embodiments of the present
formulations are moisturizing after-shaves. To that end, the
present formulations are combined with agents that are
moisturizers, emollients or humectants. Examples of useful
combinations are oils, fats, waxes, esters, fatty acid alcohols,
fatty acid ethoxylates, glycols, sugars, hyaluronic acid and
hyaluronates, dimethicone, cyclomethicone, and the like. Further
examples can be found in the International Cosmetic Ingredient
Dictionary, CTFA, Sixth Edition, 1995.
[0043] Method of Retardation of Hair Growth
[0044] The present inventive compositions are particularly useful
as hair growth retardation products. The present inventive
compositions and methods of the present invention provide a unique
combination that surprisingly retards hair growth. Hair growth can
be retarded on the face including eyebrows, upper lips, and
sideburns, on the body including legs, ears and back, and any other
area of the body where undesired hair growth may occur. The present
inventive compositions are particularly preferred to prevent hair
growth after shaving.
[0045] The present inventive method comprises administering or
topically applying to the skin a safe and effective amount of the
combination of the present invention. The amounts of the components
in the compositions will vary widely depending upon the level of
hair growth already in existence in the subject (if such exists),
the rate of further hair growth, and the level of regulation
desired.
[0046] A preferred amount of cosmetically or pharmaceutically
treating the skin is via chronic topical application of a safe and
effective amount of the novel composition to regulate hair growth.
The amount of the composition and the frequency of topical
application to the skin can vary widely, depending upon the rate of
hair growth for the individual. It is well within the purview of
the skilled artisan, such as a dermatologist or other health care
provider, to regulate pharmaceutical dosages according to patient
needs. The method of the present invention is particularly useful
after shaving.
[0047] It is suggested as an example that topical application range
from about once per week to about 4 or 5 times daily, preferably
from about 3 times a week to about 3 times daily, most preferably
about once or twice per day. In a preferred embodiment, the present
method is utilized as an aftershave and can be applied directly to
the face after shaving. The compositions will comprise from about
0.001% to 5%, preferably from about 1% to 5%, and most preferably
from about 1% to 4% of the active components.
[0048] The following examples further illustrate the invention, but
the invention is not limited thereto.
EXAMPLE 1
Clinical Study
[0049] A composition comprising the preferred embodiment was
applied on the face of male volunteers and evaluated for its
ability to make beard hair less noticeable by retarding hair
growth, lightening facial hair or reducing the appearance of 5
o'clock shadow.
[0050] Study Design:
[0051] 1. Subject Selection/Inclusion Criteria:
[0052] Fourteen men with normal to heavy and dark facial (beard)
hair, who are in good general health and free of any dermatological
disorders, were qualified for this study.
[0053] 2. Clinical Protocol:
[0054] At every visit the men arrive at the lab between 7-8 am
without shaving. They bring their razor with a new blade and
regular shave product and shave at the lab. Immediately after
shaving, closeness of shave is documented by taking close-up
photographs with the digital camera. The subjects return to the lab
after 8 hours and 24 hours and are photographed again to document 5
o'clock shadow and 24 hour beard hair growth.
[0055] At the end of the first visit the subjects are given a
product containing the inventive composition of the present
invention (hereinafter "Product"), which they use 2 times a day for
4 weeks. For the duration of this study the subjects are asked to
use the same shave product every time they shave. They are
instructed not to use the product on the day of testing. The
subjects are given a very brief questionnaire at every 8 and 24
hour time point to evaluate beard texture, color, and appearance.
At the end of the study they are given more a comprehensive
questionnaire to evaluate the product. At Weeks 1, 2, 4 and 8 the
subjects return for testing and the above procedures are repeated
every time.
1 3. Composition: Ceteareth-12 Eumulgin B-1 3.2% PEG-10 Soya Sterol
Generol 122 1% Sorbitan Sesquioleate Arlacel 83V 0.1% Glyceryl
Stearate SE Glyceryl Monostearate 2.6% 24 SE Coco-Caprylate/Caprate
Cetiol LC 3% Stearic Acid Dermofat 4919 0.1% Stearyl Alcohol/
Promulgen G-CG 0.5% Ceteareth-20 Hydrogenated Lecithin Lecinol S-10
0.1% Cholesterol NAB Cholesterol 0.2% Glycereth-26 Liponic EG1 0.2%
Octyldodecanol Eutanol G NF 0.1% Phytoshingosine
DS-Phytosphingosine 0.1% Purified Water Deionized Water 68.546%
Disodium EDTA Disodium EDTA/Trilon BD 0.1% Phenoxyethanol/
Chlorphenesin/ Glycerin/Methyl Paraben/ Benzoic Acid Germazide MPB
1% Potassium Sorbate Sorbistat K 0.1% Methylparaben Methyl Paraben
NF 0.35% Pemulen TR-1 5% (2% Disp in MethylP) (Deionized water
4.8925% Pemulen TR-1 Acrylates/C10-30 Alkyl Acrylate Crosspolymer
0.1% Methyl Paraben Methyl Paraben NF 0.0075%) Purified Water
(97.85%) Deionized Water 4% Polyquaternium-10 (2%) Polymer LR-400
(UCARE) 0.004% Butylene Glycol (0.15%) 1,3 Butylene Glycol 5%
Glycyrrhiza Glabra Glabridin 0.05% (Licorice) Extract Ursolic Acid
Ursolic Acid 90% 0.2% Cyclomethicone Dow Corning 245 Fluid 2%
Hyaluronic Acid (1% SOL) 0.5% (Purified Water (98.10%) Deionized
Water 0.4905% Sodium Hyaluronate (1%) Sodium Hyaluronate HMW 0.005%
Phenoxyethanol (.70%) Emeressence 1160 0.0035% (Rose Ether) Yeast
Extract Yeast Extract AE 1% Soy Isoflavones/ Solgen 40 0.2%
Butylene Glycol Sea Whip Extract Gorgonian Extract BG/NP 0.5%
Phenoxyethanol Emeressence 1160 0.25% (Rose Ether)
[0056] Data Analysis:
[0057] Self-assessment and product evaluation questionnaires are
compiled and the average results are shown on Tables 1-2 and FIGS.
1-2. Beard growth is evaluated from the digital photographs via
image analysis. A template of the right and left side of the face
of each subject is made and the amount of beard hair within this
area is measured at each time point. The amount of hair covering
the outlined area is directly related to hair length and therefore
to hair growth.
[0058] Results:
[0059] The results of this study show that topical treatment with a
product containing the above composition is effective in improving
beard texture, color and appearance and reducing beard growth.
Table 1 below and FIG. 1 summarize the results of the study.
2TABLE 1 Self Assessment of Beard % Improvement of Texture, Color
and Appearance 8 hours after shaving 24 hours after shaving 1 Wk 2
Wks 4 Wks 8 Wks 1 Wk 2 Wks 4 Wks 8 Wks TEXTURE 18.8 27.1 27.8 35.4
13.5 29.1 32.1 28.7 COLOR 19.4 30.1 38.6 49.0 9.1 27.5 32.5 25.6
APPEARANCE 23.8 27.4 32.1 43.6 15.0 30.2 31.3 25.6
[0060] As seen from Table 1 above and corresponding FIG. 1,
self-assessment of beard texture, color and appearance at 8 and 24
hours after shaving clearly show an improvement with product use.
After 1 week of treatment there was about a 20% improvement in
texture, color and appearance of 5 o'clock shadow (8 hours after
shaving) and it increased to about 35-50% after 8 weeks of
treatment. At the 24 hour time point there was a 10-15% improvement
after 1 week of treatment and increased to 25-30% between 2 and 8
weeks of treatment.
[0061] User's assessment of product's performance after 8 weeks of
use are shown below. The users were asked to comment on the
reduction of 5 o'clock shadow, beard growth, rate the product and
likelihood to purchase it. Table 2 below and corresponding FIG. 2
summarize these results.
3TABLE 2 Evaluation of Beard Growth Retardant Product after 8 Weeks
of use Results based on a scale from 1 (Poor)-10 (Excellent)
Comment Average Score S.D. Reduce appearance of 5 o'clock shadow
5.2 2.4 Reduce beard growth 5.0 2.2 Likelihood to buy a product
like this 5.1 3.7 Rate this product 4.9 3.3
[0062] As seen in Table 2 above and FIG. 2, on a scale of poor (1)
to excellent (10) the participants rated the composition about a
5.
[0063] Beard growth is evaluated via image analysis from close up
digital photographs. These results show that the composition was
very effective in reducing beard growth. Table 3 below and
corresponding FIG. 3 summarize these results.
4TABLE 3 Evaluation of Beard Growth Retardant Product from Digital
images via Image Analysis % Decrease in beard growth Time after
shaving 1 Week 2 Weeks 4 Weeks 8 Weeks Immediately 48.0 52.9 41.5
51.8 8 hours 48.1 73.1 77.6 83.0 24 hours 38.8 68.3 52.4 40.6
[0064] As seen from Table 3 above and corresponding FIG. 3, after
one week and up to 8 weeks of treatment there is a 40-50% beard
reduction immediately after shaving, thereby indicating a closer
shave. The best results are seen 8 hours after shaving at the 5
O'clock shadow, where after one week of treatment there is a 48%
reduction in beard growth and it steadily improves to 83% after 8
weeks. Twenty four hours after shaving there is a 38-68% reduction
in beard growth after 1-8 weeks of treatment with some variation in
the data.
[0065] Based on the results of the study in the above Example 1, it
is seen that topical treatment with the composition is effective in
improving beard texture, color and appearance and reducing beard
growth.
EXAMPLE 2
Comparative Study
[0066] The following example provides a clinical study comparing an
embodiment of the present invention with a conventional hair growth
retardation product, using a control to note the differences.
[0067] Formation of Study Panel:
[0068] Adult women are recruited from a local population. The
following criteria for inclusion and exclusion are based on the
information obtained from the candidates and from an examination of
the area that is involved in the study.
[0069] Inclusion Criteria: To be considered as a potential subject,
each candidate must:
[0070] shaved legs daily
[0071] express willingness to cooperate with the investigator;
[0072] convince the investigator that she was dependable and would
comply with the study regimen;
[0073] demonstrate the ability to understand the purpose of the
study and what was required of her to bring the study to a
meaningful conclusion;
[0074] demonstrate the ability to understand the risks associated
with participation; and
[0075] demonstrate the ability to read and understand all the items
in the informed consent document.
[0076] Exclusion Criteria: A prospective participant is excluded if
the interview or examination disclosed any of the following:
[0077] a systemic illness that contra-indicates participation;
[0078] any dermatological disorders in the areas that are to be
used in the study;
[0079] pregnant women or lactating mothers;
[0080] using systemic or topical retinoids, antihistamines or
similar agents.
[0081] Composition of Panel:
[0082] 19 women who satisfy all the requirements itemized in the
list of inclusion and exclusion criteria.
[0083] Test Products:
[0084] Product A: Inventive Composition (hereinafter "Hair Growth
Retardation Complex")
[0085] Soy Extract (0.2% Solgen 40)
[0086] Phytospingosine 90.1%)
[0087] Gorgonian Extract (0.5%)
[0088] Yeast AE (1%)
[0089] Ursolic Acid (0.2%)
[0090] Glabridin (0.05%)
[0091] Product B: Conventional Hair Growth Retardation Product
[0092] Sanguisorba Officinalis Root Extract
[0093] Product C: Traditional Moisturizer (Control)
[0094] Method of Application:
[0095] The women are instructed to apply the products to their legs
three times a day, morning, afternoon, and evening, for 8 weeks.
Group 1 applies product A to the right leg and product C to the
left leg. Group 2 applies product B to the right leg and product C
to the left leg. On the day of testing, the women do not apply the
products for at least 12 hours before measurements were taken.
Product use is monitored by a daily diary as well as assessment of
remaining package content at the end of the study.
[0096] Clinical Test Procedure:
[0097] This is a double blinded study consisting of eight weeks of
product use. The legs are the test site. The panelists refrain from
using any treatment products on the test sites except for the test
products provided. The panelists are instructed to shave their legs
four days prior to each visit. Evaluations are carried out before
product application (baseline), and at two, four, and eight weeks
during the course of treatment. The panelists report to the Testing
Center for testing.
[0098] Test Procedure:
[0099] 1. Reduction of Hair Growth
[0100] At the outset of the study a particular area on the legs of
each panelist demonstrating four days of hair growth is marked. The
images of that specific portion of the leg are obtained using a
fiber optic microscope (Hi-Scope, Vacaville, Calif.) at a
magnification of 40.times. (approximately 1 sq. cm.) Ten sites are
chosen per leg per panelist. The same area is photographed at each
time point following the initial visit. The stored images are
digitized and analyzed using an image analysis program, Optimas
6.51. The average hair length is calculated using total area 4 days
after shaving at each time point to determine the amount of hair
growth.
[0101] 2. Results
5TABLE 4 Comparative Study Results Time Point Average % Reduction
p-value Hair Growth Retardation Product Baseline 0.97 2 weeks 0.83
14% p > 0.05 4 weeks 0.82 16% p > 0.05 8 weeks 0.69 29% p
< 0.05 Conventional Hair Growth Retardation Product Baseline
1.09 2 weeks 0.94 14% p > 0.05 4 weeks 0.93 15% p > 0.05 8
weeks 0.88 20% p < 0.05 Control Baseline 1.12 2 weeks 1.12 0% p
> 0.05 4 weeks 1.19 -6%.sup. p > 0.05 8 weeks 1.12 0% p >
0.05
[0102] As can be seen in Table 4 above and corresponding FIG. 4,
the hair growth retardation product incorporating the inventive
composition reduces hair growth by 29% after 8 weeks of use, as
opposed to 20% reduction with the conventional hair growth
retardation product and 0% using the control.
EXAMPLE 3
Comparative Study
[0103] The following example provides a clinical study comparing
the inventive composition with the combination of ornithine
decarboxylase inhibitor, anti-angiogenic active and an
anti-inflammatory and the alteranate embodiment including the 5
alpha reductase inhibitor in retarding hair growth.
[0104] Formation of Study Panel:
[0105] Adult men who were interested in taking part in this study
were recruited from a local population. The following criteria for
inclusion and exclusion were based on the information obtained from
the candidates and from an examination of the area that was
involved in the study.
[0106] Inclusion Criteria: To be considered as a potential subject,
each candidate must have:
[0107] a 5 o'clock shadow
[0108] Exclusion Criteria: A prospective participant is excluded if
the interview or examination disclosed any of the following:
[0109] a systemic illness that contra-indicates participation;
[0110] any dermatological disorders in the areas that were to be
used in the study; or
[0111] uses systemic or topical retinoids, antihistamines or
similar agents.
[0112] Composition of Panel:
[0113] The panel is composed of 27 men who satisfy all the
requirements itemized in the list of inclusion and exclusion
criteria.
[0114] Test Products:
[0115] Group 1: Inventive composition with 0.1% 5 alpha reductase
inhibitor, saw palmetto.
[0116] Group 2: Inventive composition without 5 alpha reductase
inhibitor.
[0117] Method of Application:
[0118] Procedure for Shaving:
[0119] The panelists are instructed to report for all visits with a
24 hour beard growth. The men then shave with their own razor and
shaving cream. Measurements are taken immediately after shaving,
and after 8 and 24 hours.
[0120] The men are instructed to apply the product to their face
two times a day, morning and evening, for 8 weeks. On the day of
testing, the men do not apply the products for at least 12 hours
before measurements were taken. Product use is monitored by a daily
diary as well as assessment of remaining package content at the end
of the study.
[0121] Clinical Test Procedure:
[0122] This is a double blinded controlled study consisting of
eight weeks product use. The test site is the face. The men refrain
from using any treatment products on the test sites except for the
test products provided. The panelists are instructed to report to
the testing center with at least a 24 hour beard growth.
Evaluations are carried out before product application (baseline),
and after four, and eight weeks during the course of treatment.
[0123] Test Procedure:
[0124] 1. Reduction of Hair Growth
[0125] At the outset of the study a particular area on the face of
each panelist is marked. The images of that specific portion of the
face are obtained using a Fuji S-2 Digital Camera with a Canfield
epilume adaptation. The Canfield Epilume allows for close up
contact photos to be taken at a fixed distance. The same area is
photographed immediately, 8 hours, and 24 hours after shaving at
each visit. The stored images are digitized and analyzed using an
image analysis program, Optimas 6.51.
[0126] Shave Time--
[0127] At each time point the men use an electronic timer to
measure the length of time needed to shave.
[0128] Self Evaluations--
[0129] A self evaluation is performed by each panelist on the
appearance of their beard, 8 and 24 hours after shaving. The
following 10 point analog scale is used:
6 0 10 Not Noticeable Extremely Noticeable
[0130] 2. Results of Hair Retardation
7 TABLE 5 Panelists Assessment Hair Retardation of Beard Appearance
Shave 8 hours 24 hours 5 hours 24 hours Time Group 1 Inventive
Composition with 5 alpha reductase inhibitor 4 weeks 30% 29% 24%
21% 15% 8 weeks 47% 39% 30% 27% 20% Group 2 Inventive Composition
without 5 alpha reductase inhibitor 4 weeks 17% 27% 19% 15%
-6%.sup. 8 weeks 25% 38% 23% 19% 1%
[0131] As can be seen in Tables 4 and 5 above, after eight weeks of
product use with the composition containing the 5 alpha reductase
inhibitor, panelists experienced a 47% reduction in hair growth
eight hours after shaving, as compared to a 17% reduction without
the addition of the 5 alpha reductase inhibitor in the product.
Reduction in the appearance of hair growth was 30% with the 5 alpha
reductase inhibitor in the product and 23% without, eight hours
after shaving.
[0132] It should be understood that the specific forms of the
invention herein illustrated and described are intended to be
representative only. Changes, including but not limited to those
suggested in this specification, may be made in the illustrated
embodiments without departing from the clear teachings of the
disclosure. Accordingly, reference should be made to the following
appended claims in determining the full scope of the invention.
* * * * *