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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

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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.

Section snippets

Methods

The two identical studies (A and B) received approval before patient enrollment from the appropriate institutional review board for each center. They were conducted in accordance with the Declaration of Helsinki and Good Clinical Practices and in compliance with local regulatory requirements. All patients provided written informed consent before entering the studies.

Baseline characteristics

Studies A and B were identical in design and the combined data from these two studies are reported. A total of 2813 patients were enrolled across 68 investigative sites and randomly assigned to one of 4 study drug treatments: clindamycin-BPO 2.5% gel (n = 797); clindamycin phosphate 1.2% gel (n = 812); BPO 2.5% gel (n = 809); or vehicle gel (n = 395).

Demographic data (Table II) were not statistically different across all 4 treatment groups. Mean age across treatment groups was 19.3 years. There

Discussion

BPO is a safe and effective agent for treating acne. Its efficacy is maintained over many years of use with the distinct advantage of not being associated with antimicrobial resistance.2 It has been shown that lower concentrations of BPO (2.5%) can be equally efficacious to higher concentrations of BPO in reducing acne lesions.6 Importantly, the lower concentrations of BPO have reduced cutaneous side effects such as burning, erythema, and peeling.6 It is also well established that products that

Conclusions

The fixed combination of clindamycin phosphate 1.2% and BPO 2.5% in clindamycin-BPO 2.5% aqueous gel is an effective, safe, and well-tolerated topical therapy for the treatment of patients with moderate to severe inflammatory and noninflammatory acne vulgaris.

References (12)

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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.

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