Efficacy of a twice-daily, 3-step, over-the-counter skincare regimen for the treatment of acne vulgaris

BACKGROUND: Acne vulgaris (acne) is the most common skin disorder producing physical and emotional scars that can persist for years. An estimated 83% of acne sufferers self-treat, but there is lack of studies documenting the effectiveness of over-the-counter (OTC) acne treatment products. OBJECTIVE: This study was conducted to determine the effectiveness of an OTC, 3-step, anti-acne skincare regimen in treating acne and improving the appearance of red/inflamed facial skin. METHODS: This 6-week, open-label clinical study included both genders aged between 12 and 35 years with mild-to-moderate acne. All subjects were required to have an acne score of 1–3 (Cook’s acne grading scale: 0=clear to 7=very severe) and a moderate redness score of ≥2 (0=none and 4=severe). Subjects completed a 3-step facial treatment regimen every morning and evening using an OTC cleanser, toner, and acne treatment. Evaluations for effectiveness and safety were done at baseline and weeks 2, 4, and 6 using digital photographs (Visia-CR(®) digital imaging system) of the face and analyzed using Image-Pro(®) software for the grading of acne, red/inflamed skin, and the number and type of lesions. RESULTS: Thirty subjects (12 males and 18 females) were enrolled (mean age of 19 years; range 12–34 years). This skincare regimen resulted in statistically significant improvements in acne grading scores after 2 weeks of use, with mean scores continuing to improve after 4 and 6 weeks of use (P<0.001). Statistically significant improvements from baseline in red/inflamed skin, open and closed comedones, and papules were detected at all time points and for nodules at week 6, compared to their respective baselines (P<0.05). CONCLUSION: This clinical study demonstrated the effectiveness of an OTC 3-step, anti-acne skincare regimen in significantly improving acne and the overall appearance of skin in the majority of subjects who had mild-to-moderate acne.