Efficacy and Skin Microbiome Modulation Effects of a Fixed-Concentration Combination of Benzoyl Peroxide 4% Plus Niacinamide 4% in a Film-Forming Cream in Subjects with Mild-to-Moderate Acne: A Non-Sponsored, Prospective, Assessor-Blinded, Pilot Trial

Abstract

Benzoyl peroxide (BPO) and niacinamide (Niac) are commonly used alone or in combination with other molecules in the treatment of acne. BPO and Niac in the same product could exert complementary and synergistic effects improving efficacy in acne. Furthermore, Niac could reduce some side effects of BPO, such as skin irritation and erythema. A film-forming cream product containing BPO 4% and Niac 4%, vehiculated in a mixture of polyvinyl alcohol (PVA) and perfluoropolyether (PFPE) has been recently developed (B-N cream). A 28-day, assessor-blinded pilot trial was conducted to evaluate the clinical efficacy, skin tolerability, sebum production, skin redness, and skin microbiome modulation of B-N cream in subjects with mild to moderate acne of the face. Twenty-two adult men and women with mild-to-moderate acne of the face participated in this trial, after their written informed consent. B-N cream was applied once daily in the evening. The use of B-N cream was associated with a statistically significant decrease in acne lesions after treatment in comparison with baseline (non-inflammatory lesions: −40%; inflammatory lesions: −43% and total lesions: −41%). The use of the cream was not associated with a skin barrier function alteration. The skin redness score (−11%) and the sebum production (−42%) were significantly reduced after treatment. The use of B-N cream determined a reduction in the relative abundance of the Actinobacteria phylum (Corynebacterium and Propionibacterium, from 56% to 47%) and a significant increase in the abundance of Bacteroidetes phylum (from 3% to 5.2%). In addition, the product was well tolerated. In conclusion, this film-forming, medical device cream was effective in subjects with mild-to-moderate acne, reducing acne lesions and sebum production without altering skin barrier function, offering good skin tolerability. Furthermore, this product exerts positive skin microbiome modulation effects.