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Composition for Treating the Cutaneous Atrophy Associated With Patentamt Europaisches ||| || 1 1| || || || || || || || || ||| || (19) J European Patent Office Office europeen des brevets (11) EP 0 504 862 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publicationation and mention (51) Int. CI.6: A61 K 31/19, A61K 31/57 of the grant of the patent: 07.08.1996 Bulletin 1996/32 (21) Application number: 92104725.4 (22) Date of filing: 18.03.1992 (54) Composition for treating the cutaneous atrophy associated with topical steroid use comprising a salt of C3-7 alpha-hydroxy carboxylic acid Zusammensetzung zur Behandlung Steroid-induzierter Hautatrophie enthaltend ein Salz einer C3-7 Alpha-Hydroxy-Carbonsaure Composition pour le traitement de I'atrophie cutanee associee a I'utilisation de steroides contenant un sel d'acide carboxylique en C3-C7 alpha hydroxyle (84) Designated Contracting States: (56) References cited: AT BE CH DE DK ES FR GB GR IT LI LU MC NL EP-A- 0 273 202 EP-A- 0 413 528 PTSE EP-A- 0 415 766 US-A- 4 105 783 US-A- 4 246 261 (30) Priority: 19.03.1991 US 671577 • JOURNAL OF THE AMERICAN ACADEMY OF (43) Date of publication of application: DERMATOLOGY, vol. 26, no. 4, April 1992, pages 23.09.1992 Bulletin 1992/39 535-544; R.M. LAVKER et al.: "Effects of topical ammonium lactate on cutaneous atrophy from a (73) Proprietor: Bristol-Myers Squibb Company potent topical corticosteroid" New York, N.Y. 10154 (US) • CLINICAL RESEARCH, vol. 39, no. 2, 9th April 1991, page 507A; R.M. LAVKER et al.: Inventors: (72) "Reduction of corticosteroid-induced atrophy by • Prakash Parab, alpha-hydroxy acids" NY 14221 Williamsville, (US) • J.E.F. REYNOLDS: "Martindale, The Extra • Lavker, Robert Parmacopoeia", 29th edition, 1989, page 1542, Malvern, Pennsylvania (US) The Pharmaceutical Press, London, GB • Leyden, James • R. BERKOW et al.: "The Merck Manual of 19401 Haverford, Pennsylvania (US) Diagnosis and Therapy", 15th edition, 1987, 2246-2248, Merck & Co., Inc., Rahway, N J, (74) Representative: Kinzebach, Werner, Dr. et al pages US Patentanwalte • Goodman and Gilman's, The pharmacological Reitstdtter, Kinzebach und Partner basis of Ed. vol. 11 Postfach 86 06 49 therapeutics, 8, (1991), page 1556 81633 Munchen (DE) CO CM CO CO o Note: Within nine months from the publication of the mention of the grant of the European patent, give LO any person may notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in o a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. Q_ 99(1) European Patent Convention). LU Printed by Rank Xerox (UK) Business Services 2.13.0/3.4 EP 0 504 862 B1 Description Background 5 The use of topical steroids is known to result in certain unwanted side effects, among them cutaneous atrophy, or diminution of the epidermis and dermis, at or near the site of steroid application. Such atrophy is generally character- ized by thinning, shininess, increased transparency and telangiectasia. There are many regimens and a variety of reasons for treating conditions with steroids and/or hydroxyacid-based reagents. Applicants know of no references to the use of hydroxyacid salts, e.g. lactates, to ameliorate the adverse 10 effects of topical steroid usage. U.S. 4,105,783 describes the treatment of dry skin, or "ichthyosis", using the acid, amide or ammonium salt of an a- or p-hydroxyacid. Lactic acid, or a-hydroxypropionic acid, is one of the a-hydroxyacids mentioned. U.S. 4,246,261 shows topical compositions containing steroids in which the efficacy of the steroid used is enhanced via the use of salts of lactic or other a-hydroxyacids, derived using various bases. 15 U.S. 4,363,815 deals with compositions for treating skin inflammation or disturbed keratinization. Hydroxyacid/base reaction products are disclosed as useful therein. U.S. 4,485,091 refers to skin creams which contain sodium and potassium lactates as buffers. E.P.O. Publication 0273202 discloses combinations of therapeutic agents with hydroxycarboxylic acids or salts thereof. At page 16, an ointment containing betamethasone dipropionate and 2-methyl-lactic acid is recited. 20 Lac-Hydrin® lotion, a product of Westwood Squibb Pharmaceuticals, Inc. (Buffalo, N.Y.), is described on page 2285 of the 1990 Physician's Desk Reference as 12% lactic acid, neutralized with ammonium hydroxide (i.e., ammo- nium lactate). The lotion has a pH of 4.5-5.5 and is disclosed as useful in treating dry, scaly skin (xerosis), ichthyosis vulgaris and the itching associated with these conditions. EP-A-415 766 discloses the use of retinoids for reversing the effects of glucocorticoid-induced skin atrophy by top- 25 ical administration of said retinoids. Objects of The Invention It is one object of the invention to provide compositions for treating skin atrophy associated with topical steroid use. 30 It is another object to provide compositions and processes for thickening skin. It is yet another object of the invention to increase the ground substance in the viable epidermis of subjects and, thereby, ameliorate the effects of biological aging and/or damage by chemical agents or light. The Invention 35 It has been discovered that certain salts of alpha-hydroxyacids thicken the skin, specifically the viable epidermis, and increase certain dermal components (ground substance) so that the atrophic effects of topical steroid usage are lessened. In a preferred embodiment, a 0.05% clobetasol 1 7-propionate cream was applied to the skin of a group of subjects 40 every morning for four weeks. Buffered ammonium lactate (12% Lac-Hydrin®) was applied eight hours after each ster- oid application. Other groups received applications of only steroid or ammonium lactate salt once daily. Skin treated with only steroid showed a 51% decrease in thickness, while that treated with steroid followed by ammonium lactate showed only a 35% decrease in thickness. The present invention therefore relates to the use of a salt of a C2_7 alpha-hydroxyacid for preparing a composition 45 for treating skin atrophy associated with topical steroid use, for thickening skin and/or for increasing the ground sub- stance in the viable epidermis of a subject. Further, the present invention relates to the use of a salt of a C2_7 alpha-hydroxyacid for preparing a composition for decreasing the reduction in the thickness of the viable epidermis caused by contacting said epidermis with a steroid. so Advantages The invention has several advantages over other dermatological systems now in use. One principal advantage is the lessening of the cutaneous atrophy usually associated with the topical use of ster- oids and some other medicaments. 55 Another is the fact that, while lessening one or more of the side effects of such drugs as steroids, the salts of the invention do not alter the efficacy of these drugs in any way. Accordingly, there is no "masking" or "dilution" of the steroid used. Still another advantage is the compatibility of the salts of the invention with steroids and other topical therapeutic agents. The salts may be simply blended into formulations containing the steroid. 2 EP 0 504 862 B1 Thus, the salts of the invention may be administered either along with a steroid or other topical drug or in a separate step, that is, either concomitant therewith, previous thereto or subsequent thereto. It has been found that using the salt after use of the steroid can lessen the atrophic effects of the steroid without altering its beneficial effects. The salts of the invention can also be used in any system in which temporary thickening of the epidermis is desired. 5 For example, persons with known sensitivities to certain agents, e.g. sunlight or certain hair or makeup preparations, and those whose skin has become biologically aged can have their skin toughened or made less sensitive by using the systems of the invention before exposing their skin to harmful agent(s). These and other advantages of the invention will be apparent after a consideration of the following description and claims. 10 Description of the Invention Unless stated otherwise, all percentages mentioned herein are weight percentages, based on total composition weight. 15 According to the invention certain salts, optional steroids and, if desired, various additives conventionally used in topical formulations are employed. Salts 20 Useful salts are generally obtained via the reaction of suitable bases with a-hydroxyacids of formula I: R-CH-COOH (I) wherein R is H or a Ci_5 hydrocarbon group. Preferably R is an alkyl group, such as a Ci_3 alkyl group, with methyl and ethyl groups being highly preferred. R is 30 most preferably a methyl group, so that salts derived from a-hydroxypropionic acid, or lactic acid, are most preferred. Mixtures of acids may be used. The bases used to produce the salts of the invention contain either nitrogen atoms, present as ammonium ions or amine nitrogen, or metal ions. Ammonium-containing species to be used can be, for example, NH4OH, HN(R1)3OH, or N(R1)4OH, in which each 35 R1 is independently a Ci_8 alkyl or aryl group. Mixtures are operable. Ammonium hydroxide is a preferred reactant. Amines are another group of nitrogen-containing reactants which may be used to make the salts of the invention. Useful amines include organic primary, secondary and tertiary amines which contain 1-3 nitrogen atoms. The organic groups of these amines are generally Ci_8 alkyl or aryl groups, optionally substituted with one more hydroxyl groups. Preferred amines include alkanolamines, diamines, dialkylamines, dialkanolamines, alkylalkanolamines, trialkylamines, 40 trialkanolamines, dialkyl- or alkanol-amines and alkyl diethanolamines. Alternatively, the salts of the invention can be produced using metal ion-containing reagents.
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