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Oral R115866 in the treatment of moderate to severe facial acne vulgaris: an exploratory study

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Summary Background 

R115866 (RambazoleTM; 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.

Keywords: R115866; RambazoleTM; acne; retinoic acid; retinoic acid metabolism-blocking agent

Document Type: Research Article


Affiliations: 1: Private Practice in Dermatology, Nijverheidsstraat 75, B-1800 Vilvoorde, Belgium 2: Department of Dermatology, Albert Schweitzer Hospital, NL-3331 LZ Zwijndrecht, The Netherlands 3: Barrier Therapeutics NV, Cipalstraat 3, B-2440 Geel, Belgium 4: Department of Dermatology, Free University Brussels (AZ-VUB), B-1090 Jette, Belgium

Publication date: July 1, 2007


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