An Open-Label, Intra-Individual Study to Evaluate a Regimen of Three Cosmetic Products Combined with Medical Treatment of Rosacea: Cutaneous Tolerability and Effect on Hydration

Abstract

Introduction: Although rosacea management includes general skincare, previous studies have not evaluated comprehensive skincare regimens as adjuvants to other treatments. Methods: The primary objective of this open-label, intra-individual study of subjects with rosacea was to evaluate the cutaneous tolerability of a regimen consisting of Cetaphil PRO Redness Control Day Moisturizing Cream (once daily in the morning), Cetaphil PRO Redness Control Night Repair Cream (once daily in the evening) and Cetaphil PRO Redness Control Facial Wash (foam once in the morning and once in the evening). Secondary objectives were to evaluate the effect on transepidermal water loss (TEWL) and cutaneous hydration and to determine the subjects’ evaluation of efficacy, tolerability and future use. A dermatologist examined subjects and measured TEWL and cutaneous hydration on day (D) 0, D7 and D21, when subjects ranked symptoms. Subjects completed a questionnaire on D21. Results: The per-protocol population consisted of 42 subjects receiving treatment for rosacea. Eleven subjects developed adverse events, none of which were considered to be related to the skincare products. Five subjects showed signs or symptoms that were potentially associated with the skincare products that might suggest poor cutaneous tolerability; these were generally mild. TEWL decreased significantly by a mean of 17% on D7 and a mean of 28% on D21 compared with baseline (both P < 0.001). Skin hydration increased significantly by a mean of 5% on D7 (P = 0.008) and a mean of 10% on D21 (P < 0.001) compared with baseline. Subjects reported that the regimen was pleasant (98%) and effective (95%) and that it offered various benefits; 90% of subjects reported that they would like to continue to use the regimen and would buy the products. Conclusion: The skincare regimen improved skin hydration and skin barrier function in subjects receiving medical treatment for rosacea and was well tolerated. Funding: Galderma S.A.