A 2.6% Benzoyl Peroxide AV Cleanser Specifically Designed for Sensitive Skin Offers Good Efficacy and Tolerability

September 2024 | Volume 23 | Issue 9 | 764 | Copyright © September 2024


Published online August 30, 2024

doi:10.36849/JDD.8219

James Q. Del Rosso DOa,b, Thu Q. Nguyen PhDc, Christine Emesiani PharmDc, Matthew Meckfessel PhDc

aJDR Dermatology Research, Las Vegas, NVbAdvanced Dermatology and Cosmetic Surgery, Maitland, FLcGalderma Laboratories, Galderma, L.P., Dallas, TX

Abstract
Background: Mild-to-moderate acne vulgaris (AV) is common among adults, and benzoyl peroxide (BPO) has a long history of efficacy in reducing AV lesions. The efficacy of BPO is comparable for concentrations from 2.5% to 10% used as leave-on therapy, but tolerability is usually best at lower concentrations formulated in well-designed vehicles and with newer formulation methods such as micronization. This study assessed the efficacy and safety of a 2.6% BPO cleanser (Complexion Clearing AV Cleanser, CCAC) in mild-to-moderate AV. Methods: This was a single-center, open-label, 4-week study of subjects aged 18 to 45 years (n=28) with self-perceived sensitive skin and mild-to-moderate AV. CCAC was applied twice daily (morning and evening) on damp skin. Assessments included lesion counts, clinical photography with porphyrin analysis, patient self-assessment questionnaires, collection of adverse events, and standard tolerability ratings. Results: Total lesion counts were significantly reduced by week 1 of CCAC cleanser use (-25.2%, P<0.05). At week 4, AV lesions were numerically reduced but did not reach statistical significance. Additionally, there was a significant reduction of porphyrin counts at week 1 (-19.4% right side face, -28.8% left side, P<0.05 vs baseline). CCAC was well tolerated, with no significant increase in tolerability ratings at any time point compared to baseline, and patients reported good satisfaction. Conclusions: CCAC was efficacious in reducing AV lesions in as little as one week, and a trend in reduction was shown through week 4. Additionally, this 2.6% BPO cleanser was also shown to be very well tolerated and well-liked by subjects with self-perceived sensitive skin. J Drugs Dermatol. 2024;23(9):764-768. doi:10.36849/JDD.8219

INTRODUCTION

Benzoyl peroxide (BPO) has a long history of use in the management of acne vulgaris (AV) and has been formulated in a variety of concentrations and vehicles including creams, gels, and cleansers.1,2 Topical BPO products are available as both prescription and over-the-counter medications.3 Because the use of BPO has historically been limited by skin irritation (dryness, peeling, erythema, stinging, or burning), Mills et al compared three concentrations of BPO (2.5%, 5%, and 10%) to assess differences in efficacy and tolerability.2 The results using vehicle formulations designated in the study showed that tolerability was best at the 2.5% concentration, while differences in efficacy were marginal between the different concentrations.2 Since then, newer formulation methods such as micronization and microencapsulation have led to leave on BPO products with improved tolerability and bioavailability. Experimenting with these techniques and others, including changing vehicles to maximize solubility, in turn, facilitated the combination of BPO with other topical medications.3

BPO is a potent antibacterial agent, acting through the oxidation of bacterial proteins.4 BPO degrades rapidly to benzoic acid after penetrating the stratum corneum and releasing reactive oxygen species which damage bacterial cell walls.3 This antimicrobial mechanism, which is not associated with the emergence of antibiotic-resistant bacterial strains has led to recommendations for the use of BPO as an integral component of AV management in all patients with few exceptions.5,6 The exceptions include patients highly intolerant of BPO use due to marked irritation, those with true skin allergy to BPO (rare), and those undergoing treatment with oral isotretinoin. To date, no bacterial resistance to BPO has been reported, and adding BPO to AV treatment regimens containing antibiotics reduces the development of resistance in the skin exposed to BPO.7 Leyden et al showed in studies using either a leave-on or 6% cleansing formulation that BPO almost completely suppressed Cutibacterium acnes (97% reduction), including antibiotic-resistant strains.8,9