OBJECTIVE: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris. METHODS: A total of 2813 patients, aged 12 years or older, were randomized to receive clindamycin-BPO 2.5%, individual active ingredients, or vehicle in two identical, double-blind, controlled 12-week, 4-arm studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Score and subject self-assessment. RESULTS:Clindamycin-BPO 2.5% demonstrated statistical superiority to individual active ingredients and vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Visibly greater improvement was observed by patients with clindamycin-BPO 2.5% as early as week 2. No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. CONCLUSIONS:Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.
RCT Entities:
OBJECTIVE: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris. METHODS: A total of 2813 patients, aged 12 years or older, were randomized to receive clindamycin-BPO 2.5%, individual active ingredients, or vehicle in two identical, double-blind, controlled 12-week, 4-arm studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Score and subject self-assessment. RESULTS:Clindamycin-BPO 2.5% demonstrated statistical superiority to individual active ingredients and vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Visibly greater improvement was observed by patients with clindamycin-BPO 2.5% as early as week 2. No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. CONCLUSIONS:Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.
Authors: Gwinnett Ladson; William C Dodson; Stephanie D Sweet; Anthony E Archibong; Allen R Kunselman; Laurence M Demers; Nancy I Williams; Ponjola Coney; Richard S Legro Journal: Fertil Steril Date: 2011-07 Impact factor: 7.329
Authors: Gwinnett Ladson; William C Dodson; Stephanie D Sweet; Anthony E Archibong; Allen R Kunselman; Laurence M Demers; Peter A Lee; Nancy I Williams; Ponjola Coney; Richard S Legro Journal: Fertil Steril Date: 2011-06-30 Impact factor: 7.329
Authors: Gwinnett Ladson; William C Dodson; Stephanie D Sweet; Anthony E Archibong; Allen R Kunselman; Laurence M Demers; Nancy I Williams; Ponjola Coney; Richard S Legro Journal: Fertil Steril Date: 2010-12-30 Impact factor: 7.329
Authors: Richard S Legro; William C Dodson; Carol L Gnatuk; Stephanie J Estes; Allen R Kunselman; Juliana W Meadows; James S Kesner; Edward F Krieg; Ann M Rogers; Randy S Haluck; Robert N Cooney Journal: J Clin Endocrinol Metab Date: 2012-10-12 Impact factor: 5.958