A Topical Combination Regimen of Benzoyl Peroxide and Retinol Moisturizer for Mild to Moderate Acne

December 2022 | Volume 21 | Issue 12 | 1340 | Copyright © December 2022


Published online November 18, 2022

doi:10.36849/JDD.6845

Gabrielle Kosmoski BS, Dara Miller BA, Catherine Coret BS, Evren Atillasoy MD

Johnson & Johnson Consumer Inc., Skillman, NJ

Abstract

Topical therapies, in many cases over-the-counter (OTC) formulations, are available for the treatment of acne, including benzoyl peroxide (BPO), salicylic acid, and retinoids. While these agents provide therapeutic efficacy, combination regimens can offer improved outcomes due to their ability to address multiple pathways involved in acne formation, making them better suited to address the multiple factors involved in acne pathogenesis and the breadth of complexion issues associated with the condition. The present study assessed the efficacy and tolerability of a daily regimen comprised of topical low-dose (2.5%) BPO applied in the morning and topical retinol applied in the evening in 33 subjects with mild to moderate acne who completed the study. A significant reduction in global total acne count from baseline to week 12 (primary endpoint) was achieved, in addition to significant improvements in Investigator Global Assessment (IGA) of acne severity and reductions in inflammatory and non-inflammatory lesions. Treatment also significantly improved acne-complexion graded efficacy parameters (tactile surface roughness, uneven skin tone, skin blotchiness, and lack of skin clarity), and was well-tolerated, with no statistically significant (P<0.05) increases in objective or subjective facial irritation. Significant improvements from baseline to week 12 were observed for both self-assessment of facial skin conditions and quality of life (QoL) scores. No product-related adverse events (AEs) were observed in the study subjects.

J Drugs Dermatol. 2022;21(12):1340-1346. doi:10.36849/JDD.6845

INTRODUCTION

Acne vulgaris is an inflammatory skin disease characterized by proliferation of bacteria, hyperkeratinization, and increased sebum production, prevalent in approximately 85% of adolescents and young adults aged 12 to 24 years and 8% of adults aged 25 to 34 years.1,2 Acne's clinical manifestations include inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedones), oily skin, as well as complexion concerns such as uneven tone, postinflammatory hyperpigmentation (PIH), postinflammatory erythema (PIE), and scarring.3,4 Beyond its physical effects, acne can have a profoundly negative impact on the emotional lives of its sufferers, often causing depression, social avoidance, low self-esteem, among other detrimental effects.5,6 Dermatologists face a challenging and often fraught clinical scenario of having to treat a disease with a multifactorial pathophysiology in a patient population frequently dissatisfied with, and poorly adherent to, their treatment.7,8 This dilemma necessitates a holistic approach aimed at improving the overall condition of facial skin with acne while taking into account diverse variables, including acne severity, duration of disease, inflammatory and non-inflammatory lesions, as well as patient-specific concerns such as uneven skin tone and facial marks.7

Topical therapies, in many cases over-the-counter (OTC) formulations, are available for the treatment of acne, including benzoyl peroxide (BPO), salicylic acid, and retinoids. As monotherapies, however, these options can be limited by their individual mechanisms of action, making them less suited to address the multiple factors involved in acne pathogenesis and the breadth of complexion issues associated with the condition.8 Among the available OTC ingredients, BPO is considered a highly effective acne treatment due to its comedolytic, antibacterial, and anti-inflammatory efficacy.9 Notably, a study comparing BPO formulations for treating acne found that a 2.5% formulation was associated with lower rates of irritation compared to a 10% formulation.10 BPO's antibacterial properties, in particular, make it a common component of combination acne therapies.9

Topical retinoids have been the cornerstone of acne therapy since the 1970s and are effective in treating both non-inflammatory and inflammatory lesions by normalizing hyperproliferation and differentiation of the follicular epithelium, thereby preventing microcomedone formation.7,8 Retinol is a commonly used retinoid form, available without a prescription, which has been shown to lower matrix metalloproteinase expression, improve collagen synthesis, while increasing hyaluronic acid (HA), elastin production, and epidermal cell turnover.11 These changes have various ameliorative effects, including reducing the appearance of wrinkles and post-acne marks and improving