Evaluation of a Combination of Retinol, Hydroxyl-Pinacoloneretinoate (Retinsphere), An Antibacterial Agent (BIOPEP.15), Salicylic Acid and Vitamin E in Subjects Suffering from Predominant Comedonal Acne-An Italian multicenter Prospective Open study

Background: Topical retinoids are considered the first-line approach in the treatment of comedonal or mild inflammatory acne. However local tolerability of topical retinoids could be a limiting factor regarding their widespread clinical use in this setting. A new topical formulation containing two vitamin A derivatives (retinol and hydroxypinacolone retinoate, carried in a patented glycospheres system RetinSphere®), an antimicrobial peptide (Biopep.15), salicylic acid and vitamin E has been recently developed (Biretix gel ULTRA) (BR). Study aim: We evaluated in a prospective multicenter open study the efficacy and tolerability of BR in a real-life clinical condition. BR was applied one/twice daily for a total of 90 consecutive days. Subjects and methods: In a prospective 12-week trial we enrolled a total of 100 subjects (32 men and 68 women, mean age 23 years) with predominant comedonal facial acne. The primary outcome of the study was the evolution of non-inflammatory (NI-L) (comedons) and inflammatory lesions (IL) in comparison with baseline and after 30, 60 and 90 days. Secondary outcome was the evaluation of skin irritation (erythema E, desquamation D, burning sensation B, and skin xerosis X) using a semi-quantitative score from 0(no symptom) to 3(relevant symptom). In addition a global skin tolerability score (E+D+B+X: maximum score 12) was also calculated. Results: All subjects concluded the study. At baseline mean ± SD of NI-L were 30 ± 14. In comparison with baseline, NI-L number was reduced significantly to 22 ± 11 at day 30, to 16 ± 8 at day 60 and to 12 ± 8 at the end of the study period (a -60% vs. baseline) (p=0.0001; Wilcoxon Test). At baseline, the mean number of IL was 10 ± 4. Active treatment significantly reduced IL to 7± 4 at day 30, to 5 ± 4 at day 60 and to 3 ± 3 at day 90 (a -70% vs. baseline) (p=0.0001; Wilcoxon Test).The global skin tolerability score was 1.14 at day 30 and 0.42 at day 60. At the end of the study the mean global skin tolerability score was 0.26. Xerosis (very mild/mild) was reported by 24 (24%) of subjects after 30 day and by only 7 (very mild) (7%) at the end of treatment period. Conclusion: BR gel has shown to be a very effective and well tolerated treatment of mild to moderate acne reducing both non inflammatory and inflammatory acne lesions. This formulation has also good skin tolerability. BR could be considered a suitable first-line treatment for predominant Comedonal acne. Milani et al. (2016) Email: J Dermatolog Clin Res 4(3): 1072 (2016) 2/4 Central