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(12) Patent Application Publication (10) Pub. No.: US 2010/0160439 A1 MALLARD (43) Pub US 2010.0160439A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0160439 A1 MALLARD (43) Pub. Date: Jun. 24, 2010 (54) DERMATOLOGICAL COMPOSITIONS A6IP 7/2 (2006.01) COMPRISING AT LEAST ONE RETNOID A61O 19/00 (2006.01) COMPOUND, AN ANTI-IRRITANT (52) U.S. Cl. ........................................................ 514/569 COMPOUND AND BENZOYL PEROXDE (57) ABSTRACT (75) Inventor: Claire MALLARD, Mougins (FR) Dermatological compositions contain, formulated into a Correspondence Address: physiologically acceptable medium, at least one retinoid BUCHANAN, INGERSOLL & ROONEY PC compound selected from among all-trans retinoic acid, isotre POST OFFICE BOX 1404 tinoin, motretinide, and naphthoic acid compounds of for ALEXANDRIA, VA 22313-1404 (US) mula (I), and salts and esters thereof: (73) Assignee: GALDERMARESEARCH & (I) DEVELOPMENT, BIOT (FR) O (21) Appl. No.: 12/635,866 (22) Filed: Dec. 11, 2009 CO OH Related U.S. Application Data (63) Continuation of application No. PCT/EP08/05731, R filed on Jun. 11, 2008. (60) Provisional application No. 60/929.205, filed on Jun. 18, 2007. (30) Foreign Application Priority Data 19 Jun. 11, 2007 (FR) ....................................... O755658 wherein R is a hydrogenatom, a hydroxyl radical, a branched or unbranched alkyl radical having from 1 to 4 carbon atoms, Publication Classification an alkoxy radical having from 1 to 10 carbon atoms, or a (51) Int. Cl. cycloaliphatic radical which is substituted or unsubstituted, A6 IK3I/92 (2006.01) and benzoyl peroxide, and also at least one anti-irritant com A6 IK 8/368 (2006.01) pound selected from among 183-glycyrrhetinic acid, and its A6IP 7/10 (2006.01) salts and derivatives thereof. US 2010/0160439 A1 Jun. 24, 2010 DERMATOLOGICAL COMPOSITIONS the product Eclaran R) marketed by Pierre Fabre), with retin COMPRISING AT LEAST ONE RETNOD oids such as tretinoin (in particular, the product Retacnyl(R) COMPOUND, AN ANTI-IRRITANT marketed by Galderma) or isotretinoin (the product Roaccu COMPOUND AND BENZOYL PEROXDE tane(R) marketed by Laboratories Roche), or else with naph thoic acid derivatives. Naphthoic acid derivatives such as, in CROSS-REFERENCE TO particular, 6-3-(1-adamantyl)-4-methoxyphenyl-2-naph PRIORITYAPROVISIONAL APPLICATIONS thoic acid, which is commonly called adapalene (the product 0001. This application claims priority under 35 U.S.C. Differine(R) marketed by Galderma), are widely described and S119 of FR 0755658, filed Jun. 11, 2007, S120 of U.S. Pro recognized as active ingredients that are just as effective as visional Application No. 60/929.205, filed Jun. 18, 2007, and tretinoin for the treatment of acne. is a continuation/national phase of PCT/EP 2008/057310, 0018. However, to increase the effectiveness of treat filed Jun. 11, 2008 and designating the United States (pub ments, especially treatments for dermatological disorders, lished in the English language on Dec. 18, 2008 as WO and in particular, for acne, and to reduce the toxicity of the 2008/152064 A1), each hereby expressly incorporated by active ingredients (Cunliffe W. J. J. Dermatol. Treat., 2000, reference in its entirety and each assigned to the assignee 1I (suppl2), S13-S14), several categories of active ingredients hereof. are commonly administered. 0019. An article by Korkut and Piskin, J. Dermatology, 2005, 32: 169-173, reports the results of a study comparing a BACKGROUND OF THE INVENTION treatment combining application of adapalene in the evening 0002. 2. Technical Field of the Invention and application of BPO in the morning, relative to an appli 0003. The present invention relates to compositions for cation of each of the active principles alone. The authors do topical application, and to the administration thereofas cos not observe any superiority of the combined treatment over a metic or pharmaceutical products, said compositions being period of 11 weeks of treatment. useful in the treatment of dermatological disorders, and in 0020 Since the multiple application of various dermato particular, in the treatment of acne. logical products is quite laborious and demanding for the 0004 2. Description of Background and/or Related and/or patient, the value of a novel treatment which is effective on Prior Art dermatological conditions, in particular, acne, in a stable 0005 Acne is a common multi-factor pathology that composition which offers good cosmeticity, which signifi attacks skin rich in sebaceous glands (face, shoulder area, cantly improves tolerance and which makes it possible to arms and intertriginal areas). It is the most commonly occur increase patient compliance, is therefore apparent. ring form of dermatosis. The following five pathogenic fac 0021 Combinations of active agents are now beginning to tors play a determining role in the formation of acne: appear. Exemplary is the DUAC combination comprising 0006 1. genetic predisposition; clindamycin and benzoyl peroxide or combinations of anti 0007 2. Overproduction of sebum (seborrhea); biotics. Among these, also exemplary is a gel comprising at 0008. 3. androgens; least one retinoid and benzoyl peroxide as described in WO 0009 4. follicular keratinization disorders (comedogen O3/55472. esis); and 0022. However, the formulation of such a composition 0010) 5. bacterial colonization and inflammatory factors. comprising several active agents, including benzoyl peroX 0011. There are several forms of acne, the common factor ide, presents several problems. of all being attack of the pilosebaceous follicles. Exemplary 0023 First, the effectiveness of the benzoyl peroxide is are in particular, of acne conglobata, cheloid acne of the nape linked to its decomposition when it is brought into contact of the neck, acne medicamentosa, recurrent miliary acne, with the skin. It is the oxidizing properties of the free radicals necrotic acne, neonatal acne, premenstrual acne, occupa produced during this decomposition which produces the tional acne, acne rosacea, senile acne, Solar acne and common desired effect. Thus, to maintain optimum effectiveness for aCC. the benzoyl peroxide, it is important to prevent its decompo 0012 Common acne, also known as polymorphic juvenile sition before use, i.e., during storage. acne, is the most common. It comprises four stages: 0024 Now, benzoyl peroxide is a chemical compound that 0013 stage 1 corresponds to comedonic acne character is unstable, which makes it difficult to formulate in finished ized by a large number of open and/or closed comedones and products. of microcysts; 0025. The solubility and the stability of benzoyl peroxide 0014 stage 2, or papulopustular acne, is of mild to mod have been studied in ethanol, propylene glycol and various erate seriousness. It is characterized by the presence of open mixtures of polyethylene glycol 400 (PEG 400) and water and/or closed comedones, of microcysts, but also of red pap (Chellquist E. M. and Gorman W. G., Pharm. Res., 1992, Vol. ules and pustules. It mainly affects the face and leaves few 9: 1341-1346). The authors thus note that benzoyl peroxide in SCarS. Solution degrades more or less rapidly in all the solvents 0.015 stage 3, or papulocomedonic acne, is more serious studied, depending on the type of solvent and on its concen and extends to the back, the chest and the shoulders. It is tration. accompanied by a large number of Scars; 0026. The benzoyl peroxide degradation times observed 0016 stage 4, or nodulocystic acne, is accompanied by are so short that they do not make it possible to formulate a numerous Scars. It exhibits nodules and also painful Volumi product that is intended to be marketed. nous crimson pustules. 0027. It is known, moreover, that benzoyl peroxide is more 0017. The various forms of acne described above can be stable in water and in propylene glycol when it is in Suspen treated with active agents such as anti-seborrheic agents and sion (i.e., in disperse form), since it is not degraded after 90 anti-infectives, for example, benzoyl peroxide (in particular, days of storage in these solvents. US 2010/0160439 A1 Jun. 24, 2010 0028. Thus, to limit the problem of rapid instability of benzoyl peroxide in solution, it has been found to be advan tageous to formulate benzoyl peroxide in dispersed form. (I) 0029. Another difficulty to be overcome in the formulation of a composition comprising both a retinoid, an anti-irritant and benzoyl peroxide is that most retinoids are particularly OH sensitive to natural oxidation, to visible light and to ultraviolet radiation. Since benzoyl peroxide is a strong oxidizing agent, the chemical compatibility of these compounds in the same formulation presents many problems of stability from the physical and chemical point of view. 0030. In addition, it has been reported that benzoyl perox ide can sometimes induce dryness of the skin and on certain occasions irritation of the skin. 0031. Among the retinoids commonly employed, ada palene in particular, exhibits a unanimously proven effective ness. However, it would be advantageous and useful to reduce the irritation caused by retinoids applied topically, including wherein R is a hydrogenatom, a hydroxyl radical, a branched adapalene, although its tolerance is greater than that of its or unbranched alkyl radical having from 1 to 4 carbon atoms, competitors belonging to the same chemical category (tretin an alkoxy radical having from 1 to 10 carbon atoms or a oin, tazarotene). cycloaliphatic radical which is substituted or unsubstituted, at 0032. The term “irritation” means, in particular, the symp least one anti-irritant compound selected from among 186 toms or the conditions linked to the application to the skin of glycyrrhetinic acid (enoXolone), its salts and its derivatives, chemical products of natural or synthetic origin, used in cos and benzoyl peroxide. metics or dermatology, and which can be characterized in particular, by an inflammation, an erythema, an oedema, red DETAILED DESCRIPTION OF BEST MODE ness, itching, pain, burning, a sting, or else tingling. AND SPECIFICAPREFERRED EMBODIMENTS OF THE INVENTION SUMMARY OF THE INVENTION 0038. In one particular embodiment of the invention, the retinoid compound is a naphthoic acid compound of formula 0033.
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