27884 A multicenter clinical study to evaluate the efficacy and tolerance of a benzoyl peroxide and retinol regimen in the treatment of mild to moderate acne vulgaris

Abstract

Acne vulgaris is a multifactorial skin disease, characterized by proliferation of bacteria, hyperkeratinization, inflammation, and excess sebum production. Acne sufferers want to address all aspects of their acne, including the disease state of the lesions and cosmetic complexion issues, such as marks, tone, and redness. One first-line topical treatment for mild to moderate acne that dermatologists recommend is a combination of benzoyl peroxide (BPO), to target the bacteria, and a retinoid, to promote surface cell turnover. A daily regimen of 2.5% BPO and a stabilized cosmetic retinol was evaluated for its ability to improve acne and overall complexion. This is a novel OTC regimen for a holistic approach for both acne and complexion concerns. A 12-week, multi-center, evaluator-blinded clinical study of an acne treatment regimen (2.5% BPO applied in the morning and retinol in the evening) was conducted to evaluate its efficacy and tolerance in subjects (aged 12-30) with mild to moderate acne. The primary efficacy variable was percent change from baseline to week 12 in total lesion counts, with secondary assessments: Investigator Global Acne assessment, and additional Investigator efficacy assessments on complexion, self-assessments, and skin tolerance. A total of 33 subjects completed the study. The regimen of BPO and retinol significantly reduced total lesion counts over the 12-week study compared with baseline (P ˂ .05). Subjects reported significant improvements (P ˂ .05) in their acne, overall skin appearance and complexion. This offers patients an OTC option for addressing the acne lesions along with complexion endpoints (pigmentation, redness, overall complexion evenness) while being well-tolerated.