title: A novel gel formulation of 0.25% tretinoin and 1.2% clindamycin phosphate: efficacy in acne vulgaris patients aged 12 to 18 years.
abstract: Treatments for mild to moderately severe acne usually combine retinoid and antimicrobial therapy. Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12-week, multicenter, double-blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52-week safety follow-up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA's effects on acne lesion prevalence in 12- to 18-year-old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p < or = 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris.
authors.affiliation: Rady Children's Hospital and University of California, San Diego, San Diego, California 92123, USA. leichenfield@rchsd.org
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.forename: Mitchell
authors.initials: M
authors.lastname: Wortzman
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage*; D008297:Male; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005782:Gels; D007641:Keratolytic Agents; D002981:Clindamycin; D014212:Tretinoin; C007084:clindamycin phosphate