A Randomized Controlled Double-Blinded Split-Face Prospective Clinical Study to Assess the Efficacy, Safety, and Tolerability of a Novel 3-Step Routine Compared to Benzyl Peroxide for the Treatment of Mild to Moderate Acne Vulgaris

Abstract

AbstractAdult acne vulgaris affects up to 43-51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid and graduated retinol regimen (Geologie Clear System) versus a common OTC BPO-based regimen (Proactiv Solution) over 12 weeks. A total of 37 adult subjects with selfreported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, Geologie outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. “I would use this in the future), performance (“my skin improved” and “helped my acne clear up faster”). Geologie users reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (Geologie) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability Geologie was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p=0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris.