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Oral R115866 in the treatment of moderate to severe facial acne vulgaris: an exploratory study
Author(s) -
Verfaille C.J.,
Coel M.,
Boersma I.H.,
Mertens J.,
Borgers M.,
Roseeuw D.
Publication year - 2007
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2007.07896.x
Subject(s) - acne , medicine , tolerability , lesion , tretinoin , dermatology , gastroenterology , adverse effect , retinoic acid , surgery , biochemistry , chemistry , gene
Summary Background R115866 (Rambazole TM ; Barrier Therapeutics NV, Geel, Belgium), a new‐generation retinoic acid metabolism‐blocking agent, is a nonretinoid compound enhancing intracellularly the endogenous levels of all‐ trans ‐retinoic acid by blocking its catabolism. By virtue of this property, and the proven positive effects of retinoids in the treatment of acne, R115866 could potentially be a useful drug for acne. Objectives To explore the efficacy, safety and tolerability of systemic R115866 in male patients with moderate to severe facial acne vulgaris (at least 15 papules and/or pustules and at least two nodulocystic lesions). Methods In this exploratory trial, 17 patients were treated with oral R115866 1 mg once daily for 12 weeks, followed by a 4‐week treatment‐free period. Results At the end of treatment (week 12, n = 16) a mean reduction in inflammatory lesion count of 77·4% ( P < 0·001), in noninflammatory lesion count of 58·3% ( P < 0·001) and in total lesion count of 76·0% ( P < 0·001) was observed as compared with baseline. All lesion counts were significantly reduced from week 4 onwards. Mild side‐effects were reported occasionally. Conclusions The current data indicate that treatment with oral R115866 1 mg once daily for 12 weeks in patients with moderate to severe facial acne vulgaris is efficacious and well tolerated and merits further investigation.