The acne-specific quality of life (Acne-QoL) questionnaire was developed to measure the impact of facial acne across 4 domains (acne symptoms, role-emotional, self-perception, role-social) of health-related quality of life (HRQL). This analysis assessed the impact of clindamycin phosphate 1.2%-benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) gel on HRQL in a combined study population (N = 2813) of participants with moderate to severe acne vulgaris. Although the results presented within do not include factors of study and study-by-treatment interaction, analyses were performed to confirm that the results were consistent across the 2 identical, double-blind, randomized studies and within each treatment group across studies to justify pooling the data from both studies. The Acne-QoL questionnaire was administered at baseline and at the end of treatment (week 12). Treatment with clindamycin-BPO 2.5% gel significantly improved participant-reported HRQL across all 4 domains compared with individual active ingredients and vehicle (P < .001). The percentage improvement in mean Acne-QoL domain scores with clindamycin-BPO 2.5% gel ranged from 37% to 59%. Because the negative impact of facial acne on HRQL is one of the primary motivators for patients to seek treatment, this analysis underscores the importance of physicians incorporating assessments of HRQL into their clinical decision making.

BACKGROUND:Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments.OBJECTIVE:To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations.METHODS:Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies.RESULTS:Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator's global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity.CONCLUSION:Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.

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. (J Am Acad Dermatol 2008;59:792-800.)