Document Detail

The Tolerability Profile of Clindamycin 1%/Benzoyl Peroxide 5% Gel vs. Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel for Facial Acne: Results of Two Randomized, Single-Blind, Split-Face Studies.
MedLine Citation:
PMID:  22808305     Owner:  NLM     Status:  PubMed-not-MEDLINE    
OBJECTIVE: To compare the first two weeks of tolerability of clindamycin/benzoyl peroxide gel versus adapalene/benzoyl peroxide gel followed by six weeks of open-label clindamycin/benzoyl peroxide gel therapy in subjects with mild-to-moderate acne who participated in two eight-week, identically designed, clinical studies.
METHODS: Using a split-face method, patients received both clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel once daily for two weeks (allocation to the right or left side of the face was randomized) in an investigator-blinded fashion. Patients then went on to receive a further six weeks of open-label, full-face clindamycin/benzoyl peroxide gel. The primary outcome was to compare signs and symptoms of tolerability during the first two weeks of treatment using an investigator-assessed 4-point rating scale. Secondary endpoints included assessment of acne severity (Investigator Static Global Assessment and lesion counts), quality of life, product acceptability/preference, and patient assessments of tolerability and safety.
RESULTS: Of the 76 subjects enrolled in the two studies, 72 completed them. Overall both products were well tolerated, but mean scores for erythema, dryness, and peeling were significantly higher with adapalene/benzoyl peroxide gel than with clindamycin/benzoyl peroxide gel at both Weeks 1 and 2 (p<0.03). Patients also rated clindamycin/benzoyl peroxide gel significantly more tolerable than adapalene/benzoyl peroxide gel for redness, dryness, burning, itching, and scaling at Weeks 1 and 2 (p 0.0073). Mean Investigator Static Global Assessment score improved with both products during the first two weeks of treatment and continued to show significant improvement versus baseline when treatment with clindamycin/benzoyl peroxide gel was continued for a further six weeks (p<0.001 at Week 8). Lesion counts improved throughout the study with significant reductions from baseline occurring at Weeks 5 and 8 (p<0.0001 for both time points for total lesion counts). Clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel were well tolerated, with most adverse events of mild-to-moderate severity.
CONCLUSION: Clindamycin/benzoyl peroxide gel had better tolerability with regard to erythema, dryness, and peeling than adapalene/benzoyl peroxide gel during the first two weeks of treatment.
Lawrence Green; Marcela Cirigliano; Jennifer A Gwazdauskas; Pablo Gonzalez
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of clinical and aesthetic dermatology     Volume:  5     ISSN:  1941-2789     ISO Abbreviation:  J Clin Aesthet Dermatol     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-07-18     Completed Date:  2012-08-23     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  101518173     Medline TA:  J Clin Aesthet Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  16-24     Citation Subset:  -    
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