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Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Online ISSN 1827-1820
Ada LO SCHIAVO 1, Rosa V. PUCA 1, Francesca ROMANO 1, Massimo MILANI 2
1 Clinica di Dermatologica SUN, II Università di Napoli, Naples, Italy; 2 Medical Direction Difa Cooper IFC Group, Caronno Pertusella, Varese, Italy
BACKGROUND: A spray formulation containing 2 vitamin-A derivatives (hydroxypinacolone retinoate and retinol) carried in glycospheres (RetinSphere®) combined with an antimicrobial peptide (BIOPEP-15), salicylic acid and vitamin E (BR) has been recently developed for the treatment of truncal acne. We evaluated clinical efficacy of BR in comparison with two commonly used sprays, containing triethylcitrate and ethylinoleate (AK) and containing betaine, glycine and salicylic acid 2% (SP). The products were applied twice daily.
METHODS: In a randomized, parallel-groups, assessor-blinded, 6-week trial, we enrolled 75 subjects (38 men, 37 women, mean age 21 years) with mild-to-moderate truncal acne. Twenty-five subjects were randomized to each treatment group (BR, AK or SP). Primary outcome of the study was the evolution of Global Acne Grading System (GAGS) score in comparison with baseline and within groups at week 6. Secondary outcome was the evaluation of skin irritation.
RESULTS: All but 2 subjects concluded the study. At baseline mean±SD of GAG scores were 9.8±7 in BR, 10.7±7.6 in AK and 10.7±7.0 in SP groups, respectively. At week 6 GAGS score in BR was statistically significantly lower in comparison with AK and SP (p=0.03). A significant greater percentage reduction of GAG scores in comparison with baseline was observed in BR group (-72%) in comparison with AK group (-45%) (p=0.05) and with SP group (-36%) (p=0.009). No significant differences between the groups were observed regarding erythema, burning and xerosis scores at week 6. Twelve subjects out of 25(48%) in BR group, 15(60%) in AK group and 14(56%) in SP group reported some grade of erythema, burning or xerosis.
CONCLUSIONS: BR spray showed to be a more effective treatment of mild-to-moderate truncal acne in comparison to AK and SP sprays. This formulation showed also good skin tolerability comparable with anti-acne sprays not containing vitamin-A derivatives (Trial registration number: ISRCTN38383374).