Safety Assessment of a Novel Topical Vehicle for Personalized Treatments in Acne

Abstract

Acne vulgaris is a common inflammatory disease of the pilosebaceous unit, with a profound impact on the quality of life of patients. In this work, we aimed to study the safety characteristics of Cleoderm TM , a novel functional semisolid vehicle developed for the compounding of treatments for acne and oily skin. The primary and cumulative irritation and sensitization potential were evaluated in 54 healthy volunteers in a comparative single-blinded study, while the acnegenic and comedogenic potential of the product were assessed in 31 healthy volunteers with combination to oily skin through a non-comparative study. Cleoderm TM was applied (0.05 g/cm 2 ) in filter paper discs in both studies. For the evaluation of the irritation and sensitization potential, the investigational product, or a control (0.9% NaCl) was applied to the right or left scapular area of the study subjects. No clinical reactions were observed during the induction or challenge phases, suggesting that Cleoderm TM presents no irritating or allergenic potential. Regarding acnegenicity and comedogenicity, no significant increase in the number of acne lesions linked to the application of the product in four areas of the face was reported, indicating that Cleoderm TM appears not to display acnegenic and comedogenic potential. Furthermore, over 60% of the study subjects exhibited a decrease in the number of acne lesions after product use. These results show that Cleoderm TM exhibited no irritating, sensitizing, acnegenic or comedogenic potential, and suggest that it can be considered safe under the study conditions and that the claims dermatologically tested, clinically tested, and non-comedogenic/acnegenic can be supported.