Michael H Gold1, Andrew Korotzer2. 1. Gold Skin Care Center and Tennessee Clinical Research Center, Nashville, Tennessee; 2. Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Abstract
BACKGROUND: Acne vulgaris is commonplace and can be difficult to manage. Providing an effective and well-tolerated treatment may lead to improved adherence, increased patient satisfaction, and improved clinical outcomes. METHODS: A review of efficacy, safety, and cutaneous tolerability of clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel in 498 patients with moderate-to-severe acne vulgaris enrolled in a multicenter Phase III study randomized to receive active or vehicle once daily for 12 weeks, including the most recent post-hoc analyses. RESULTS: Significantly superior reductions in lesion counts were observed with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel from Week 4, with median percent reductions in inflammatory and noninflammatory lesions from baseline of 68.4 and 57.9 percent, respectively (bothp<0.001 versus vehicle). More than half (55.1%) of the severe acne vulgaris patients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel achieved ≥2-grade improvement from baseline in their Evaluator's Global Severity Score, and almost a third of the adolescent acne vulgaris patients (32.4%) achieved at least a marked improvement in their acne vulgaris as early as Week 2. In adult female acne overall treatments success was achieved in 52.7 percent of patients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel. Overall, and in the specific subpopulations, clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel was well-tolerated with a similar adverse event profile to vehicle. LIMITATIONS: Post-hoc analyses from a single clinical trial with demographic imbalances that could potentially confound the results. CONCLUSION:Clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel appears to be effective in treating acne across various clinically relevant sub-groups.
RCT Entities:
BACKGROUND:Acne vulgaris is commonplace and can be difficult to manage. Providing an effective and well-tolerated treatment may lead to improved adherence, increased patient satisfaction, and improved clinical outcomes. METHODS: A review of efficacy, safety, and cutaneous tolerability of clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel in 498 patients with moderate-to-severe acne vulgaris enrolled in a multicenter Phase III study randomized to receive active or vehicle once daily for 12 weeks, including the most recent post-hoc analyses. RESULTS: Significantly superior reductions in lesion counts were observed with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel from Week 4, with median percent reductions in inflammatory and noninflammatory lesions from baseline of 68.4 and 57.9 percent, respectively (bothp<0.001 versus vehicle). More than half (55.1%) of the severe acne vulgarispatients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel achieved ≥2-grade improvement from baseline in their Evaluator's Global Severity Score, and almost a third of the adolescent acne vulgarispatients (32.4%) achieved at least a marked improvement in their acne vulgaris as early as Week 2. In adult female acne overall treatments success was achieved in 52.7 percent of patients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel. Overall, and in the specific subpopulations, clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel was well-tolerated with a similar adverse event profile to vehicle. LIMITATIONS: Post-hoc analyses from a single clinical trial with demographic imbalances that could potentially confound the results. CONCLUSION:Clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel appears to be effective in treating acne across various clinically relevant sub-groups.
Authors: Diane Thiboutot; Harald Gollnick; Vincenzo Bettoli; Brigitte Dréno; Sewon Kang; James J Leyden; Alan R Shalita; Vicente Torres Lozada; Diane Berson; Andrew Finlay; Chee Leok Goh; María Isabel Herane; Ana Kaminsky; Raj Kubba; Alison Layton; Yoshiki Miyachi; Montserrat Perez; Jaime Piquero Martin; Marcia Ramos-E-Silva; Jo Ann See; Neil Shear; John Wolf Journal: J Am Acad Dermatol Date: 2009-05 Impact factor: 11.527
Authors: Brad A Yentzer; Rachel A Ade; Julie M Fountain; Adele R Clark; Sarah L Taylor; Alan B Fleischer; Steven R Feldman Journal: Cutis Date: 2010-08
Authors: Brigitte Dréno; Diane Thiboutot; Harald Gollnick; Andrew Y Finlay; Alison Layton; James J Leyden; Eric Leutenegger; Montserrat Perez Journal: Int J Dermatol Date: 2010-04 Impact factor: 2.736