An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: Assessment of efficacy and safety in 2813 patients
Accepted 24 June 2008. published online 22 September 2008.
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.
aDepartment of Dermatology, the Pennsylvania State University College of Medicine, Hershey, Pennsylvania
bDepartment of Dermatology, Gwinnett Clinical Research Center, Snellville, Georgia
cJefferson Dermatology Service, Wilmington Department of Veterans Affairs Medical Center, Wilmington, Pennsylvania
dDow Pharmaceutical Sciences Inc, Petaluma, California
eArcutis Pharmaceuticals, Redwood City, California
Reprint requests: Diana Chen, MD, Medical Affairs, Arcutis Pharmaceuticals, 900 Island Drive, Suite 210, Redwood City, CA 94065.
Supported by Arcutis Pharmaceuticals.
Disclosure: Dr Thiboutot has been an investigator, consultant, or advisory board member for Allergan Inc, Arcutis Inc, Dusa Inc, Galderma Inc, Stiefel Inc, QLT Inc, and Medicis Inc, and has received honoraria or grant support. Dr Zaenglein has served as an advisory board member for Sanofi Aventis Inc, a speaker for Galderma Inc, an investigator for Arcutis Inc, and has received honoraria or grant support. Dr Weiss has served as an investigator and consultant for Arcutis Inc and has received grant support. Dr Webster has served as an investigator and consultant for Arcutis Inc, a consultant for Allergan Inc, Stiefel Inc, Sanofi Aventis Inc, Dusa Inc, Medicis Inc, Ortho Inc, QLT Inc, Galderma Inc, Coria Inc, Cutanea Inc, and has received honoraria or grant support. Mr Calvarese is an employee of Dow Pharmaceutical Sciences, Inc. Dr Chen is an employee of Arcutis Pharmaceuticals.
ABSTRACT