Oral R115866 in the treatment of moderate to severe facial acne vulgaris: an exploratory study.
BACKGROUND
R115866 (Rambazole; 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.


OBJECTIVE
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.
Verfaille
C J
CJ
Department of Dermatology, GROW, Maastricht University, Maastricht, The Netherlands. cverfaille@barriertherapeutics.be
Coel
M
M
Boersma
I H
IH
Mertens
J
J
Borgers
M
M
Roseeuw
D
D
D000152:Acne Vulgaris / Q000517:prevention & control*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D052160:Benzothiazoles / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D014212:Tretinoin / Q000008:administration & dosage*; D014230:Triazoles / Q000008:administration & dosage*
D052160:Benzothiazoles; D003879:Dermatologic Agents; D014230:Triazoles; D014212:Tretinoin; C406527:R 115866