Cutaneous acceptability of a moisturizing cream in subjects with sensitive skin

Background Topical cosmetic products can cause adverse reactions in some individuals, particularly those with sensitive skin who may develop irritations or allergic contact dermatitis. Evidence suggests that the frequency of self-reported sensitive skin is increasing in the general population, placing greater importance on clinical testing of topical cosmetics for potential skin reactivity. Objectives To confirm the cutaneous acceptability under normal conditions of use of a moisturizing cream in individuals with sensitive skin. Methods This was a prospective, single-center, open-label, noncomparative clinical trial conducted in female subjects aged 18-60 years with Fitzpatrick skin phototype I-IV and confirmed sensitive skin. Subjects applied the moisturizer twice daily to the body and/or face for 21 +/- 2 days. Product acceptability was based on the occurrence of adverse events, investigator assessment of skin adverse reactions, and subjects' self-reported feelings of skin discomfort. Results Thirty-five female subjects initiated and completed the study; mean age was 43.2 years and most (89%) had Fitzpatrick skin phototype I-III. No adverse events or skin adverse reactions of erythema, edema, or skin desquamation were observed. There were no participant reports of skin dryness, prickling, or stinging on any occasion. One subject reported a single event of mild itching, which was considered by the investigator as probably not related to study product. Conclusions These findings suggest that the moisturizing cream was well tolerated under normal conditions of use and appropriate for topical use on sensitive skin.