Efficacy and Tolerability of a Novel Cosmetic and Over-the-Counter Facial Acne Regimen Versus a Prescription Treatment.

Abstract

Background: The SkinMedica Acne Treatment Platform (SM Regimen) was formulated to treat acne without overdrying the skin. We evaluated efficacy and tolerability of the SM Regimen (including a novel 1% salicylic acid Acne Clarifying Cleanser and 2% salicylic acid Acne Treatment Lotion) versus a prescription formulation (Rx Regimen; including adapalene 0.1%/benzoyl peroxide 2.5%) in a diverse population of adults with mild to moderate facial acne.

Methods: This single-center, double-blind, randomized study enrolled adults (18-45 years) with Fitzpatrick skin types (FST) I-VI. SM Regimen or Rx Regimen was applied topically to the entire face for 12 weeks. Assessments were conducted at 24 and 48 h and 4, 8, and 12 weeks.

Results: Subjects (SM Regimen, n = 31; Rx Regimen, n = 23) were primarily female (90.7%) with mean age of 28.6 years; 53.8% had FST IV-VI. Efficacy was comparable between regimens. The SM regimen resulted in significant improvements versus baseline in mean Investigator's Global Assessment of acne severity from 48 h through week 12 (p ≤ 0.001), as well as significant and sustained improvements from baseline in total acne lesion count, global postinflammatory hyperpigmentation/postinflammatory erythema, and oiliness. The SM Regimen was well tolerated at all time points, with mean scores below mild for all parameters; the Rx Regimen caused significantly more tightness/dry feeling at week 4 versus SM Regimen (p = 0.008). Subjects (> 96%) reported high satisfaction with the SM Regimen at all time points.

Conclusions: The SM Regimen reduced acne severity and skin oiliness, evening out skin tone without overdrying or irritating the skin.