Method of applying alpha hydroxy acids for treating striae diste

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...

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A61K 3578

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active

057600791

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BRIEF SUMMARY
This is a 371 of PCT/US95/06473 filed May 23, 1995.


FIELD OF THE INVENTION

The present invention is directed to a method of treating lesions of striae distensae, more particularly, to a method of preventing striae albae lesions, reducing the size of lesions of both striae albae and striae rubrae, as well as reducing the color of striae rubrae marks.


BACKGROUND OF THE INVENTION

Striae distensae lesions are skin stretch marks, and are most common in women, after puberty or after a first pregnancy. Skin stretch marks originate because of stretching of the skin from weight gain, or mechanical stresses, such as from strenuous exertion, weightlifting and the like. Approximately 50 percent of pregnant women will develop striae distensae skin stretch marks, on the thighs, abdomen and/or breasts. Striae distensae may also be present in cachectic states, such as tuberculosis and typhoid fever, and may be caused by rapid dieting.
Striae distensae stretch marks begin as an inflammation, such as striae rubrae, and progress ultimately to the white stretch marks known as striae albae. The earlier stage striae rubrae are red, elevated, linear lesions. Later they flatten and the redness fades, resulting in a permanent, undulating depressed line, which is the striae albae. Previously, stretch marks were thought to be permanent.
Treatment of striae distensae has been discussed in the prior art. P. Zheng et al., in "Anatomy of Striae", British Journal of Dermatology, 112:185-193 (1985), reports that striae albae are scars from an inflammatory process that destroys elastic fibers.
Nigam reports the beneficial treatment of striae distensae with retinoic acid in "Striae Cutis Distensae" Inter Journal of Dermatology September 1989 p.426-428.
Retinoic acid has been previously applied topically to the skin for the treatment of many other skin disorders, such as described in Thomas et al., "The Therapeutic Uses of Topical Vitamin A Acid", Journal of the American Academy of Dermatology, 4:505-513 (1981), wherein the use of tretinoin is shown to have a beneficial anti-inflammatory action for treating chronic skin dermatoses such as psoriasis and lichen planus.
According to U.S. Pat. No. 4,603,146 to Kligman, topical retinoic acid is shown to be effective to cause the formation of new collagen fibers, generate blood vessels, correct abnormalities in elastic fibers, and eliminate neoplastic growths in chronically sun damaged skin. Retinoic acid is also suggested for treating sun damaged skin as a result of excessive exposure to ultra-violet radiation. U.S. Pat. No. 5,143,163, also to Kligman, describes the treatment of striae distensae skin stretch marks with retinoic acid.
Elson reports treatment of striae distensae with topical tretinoin in Treatment of Striae Distensae with Topical Tretinoin" J. Dermatol Surg Oncol 16:3 March 1990 p.267-269.
Further, U.S. Pat. No. 4,054,649 to Cariel discloses the treatment of skin stretch marks with compositions containing alchemilla used in the form of concentrated hydroglycolic extracts, such as phytelenes, sorbitolisates, oleates, glycerisates, glycolisates, hydroglycolisates, hydroalacoholisates and the like.
Cariel '649 patent is concerned with a composition which contains hydroglycolic extracts, which are very different from an alpha hydroxy acid, such as glycolic acid.
Moreover, extract of Alchemilla, as with other crude natural extracts, may contain 10-100 thousand or more organic compounds, which can only be demonstrated to be present by using the most sophisticated and sensitive chemical detection methods. An end use patent utilizing a dozen well chosen natural crude extracts would therefore cover the great majority of naturally occurring carbon compounds for this end use.
Therefore, while glycolic acid may exist in trace amounts in Alchemilla, this is similar to trace amounts found in any biological organism when properly assayed with a nuclear magnetic resonance (NMR) mass spectrophotometric methodology.
In addition, Cariel '649 claims pharmaceutical activity for the extract of Alc

REFERENCES:
patent: 4054649 (1977-10-01), Cariel
patent: 4105782 (1978-08-01), Yu et al.
patent: 4234599 (1980-11-01), Van Scott et al.
patent: 4363815 (1982-12-01), Yu et al.
patent: 4424234 (1984-01-01), Alderson
patent: 4603146 (1986-07-01), Kligman
patent: 5091171 (1992-02-01), Yu et al.
patent: 5134163 (1992-07-01), Kligman
patent: 5153230 (1992-10-01), Jaffrey
patent: 5444091 (1995-08-01), Rapaport
P. Zheng et al. "Anatomy of Striae", British Journal of Dermatology, 112:185-193 (1985).
P. Nigam, "Striae Cutis Distensae", Inter Journal of Dermatology, Sept. 1989 pp.426-428.
Thomas et al. "The Therapeutic Uses of Topical Vitamin A Acid", Journal of the American Academy of Dermatology, 4:505-513 (1981).
Elson et al. Treatment of Striae Distensae with Topical Trentinoin J. Dermatol Surg Oncol 16:3, Mar. 1990, pp.267-269.
Lavker et al. "Effects of Topical Ammonium Lactate on Cutaneous Atrophy from a Potent Topical Corticosteroid", Journal of the American Academy of Dermatology, (1992) pp.535-543.

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