title: Efficacy and tolerability of fixed-combination acne treatment in adolescents.
abstract: Acne is common among adolescents and can be difficult to manage. Providing an effective treatment method that offers an early onset of action and a favorable tolerability profile may lead to improved adherence, increased satisfaction, and improved clinical outcomes in this patient population. A post hoc analysis was conducted of 1755 adolescents (age range, 12 to < 18 years) with moderate to severe acne who had been enrolled in 2 double-blind, multicenter studies and were randomized to receive either clindamycin phosphate (CP) 1.2%-benzoyl peroxide (BPO) 2.5% gel, CP 1.2%, BPO 2.5%, or vehicle once daily for 12 weeks. Significantly superior reductions in inflammatory, noninflammatory, and total lesion counts were observed in the CP 1.2%-BPO 2.5% gel group versus the other 3 groups (P < or = .002 for all week 12 pairwise comparisons). At week 12, treatment success with CP 1.2%-BPO 2.5% gel was statistically superior to CP 1.2% (P = .004), BPO 2.5% (P = .031), and vehicle (P < .001). Participants observed improvement with CP 1.2%-BPO 2.5% gel treatment as early as week 2, with 31.4% of participants reporting their skin was clear, almost clear, or showed marked improvement. Clindamycin phosphate 1.2%-BPO 2.5% gel was associated with a low incidence of treatment-related adverse events (AEs) and a favorable cutaneous tolerability profile. Clindamycin phosphate 1.2%-BPO 2.5% gel is an effective, safe, and well-tolerated treatment in adolescents with moderate to severe acne. The once-daily regimen, early signs of improvement, favorable cutaneous tolerability profile, and participant satisfaction may lead to increased adherence and improved clinical outcomes.
authors.affiliation: Department of Dermatology, Henry Ford Medical Center, Detroit, MI 48202, USA. lstein1@hfhs.org
authors.forename: Linda Stein
authors.initials: LS
authors.lastname: Gold
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C466951:clindamycin phosphate benzoyl peroxide combination; D002981:Clindamycin; D001585:Benzoyl Peroxide