A combined analysis of 2 randomized clinical studies of tretinoin gel 0.05% for the treatment of acne.
Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.
DFB Pharmaceuticals, Inc, Fort Worth, Texas, USA.
Guy
G
Webster
D Innes
DI
Cargill
John
J
Quiring
Cullen T
CT
Vogelson
Herbert B
HB
Slade
D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D017326:Clinical Trials, Phase III as Topic; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use*
D003879:Dermatologic Agents; D005782:Gels; D014212:Tretinoin