Loïc Vaillant1, Gabriela Georgescou1, Constance Rivollier2, Alain Delarue3. 1. CHRU Dermatology Department, University of Tours, INSERM U 1253 iBrain, Tours, France. 2. Dermatology Department, Hôpital des Peupliers, Paris, France. 3. Pierre Fabre Dermatologie, Lavaur, France.
Abstract
BACKGROUND: The stratum corneum plays an important protective physiological role in providing a barrier to preventing skin desiccation and penetration of external agents. Emollients are used commonly to improve barrier function and skin hydration. AIMS: The primary objective of this study was to evaluate the effect of an emollient, V0034CR cream, and its active ingredients, to restore the cutaneous barrier. Secondary objectives included assessment of the moisturizing activity of each product and tolerance. The study was not designed to evaluate therapeutic benefit. METHODS: In this randomized, double-blind, 4-arm crossover, clinical pharmacology study, the full emollient V0034CR, its vehicle formulation alone, or with glycerol, or petrolatum, was applied to the forearms of healthy volunteers (n = 51) with dry skin (Kligman score of 2 or 3). Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry were serially measured for 12 hours following application. An analysis of variance with repeated measures was performed on the evolution of TEWL and corneometry. RESULTS: V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001). CONCLUSIONS: The emollient V0034CR presented combined effects, with the petrolatum component improving skin barrier function, with a reduction in TEWL, and the glycerol component improving skin hydration.
RCT Entities:
BACKGROUND: The stratum corneum plays an important protective physiological role in providing a barrier to preventing skin desiccation and penetration of external agents. Emollients are used commonly to improve barrier function and skin hydration. AIMS: The primary objective of this study was to evaluate the effect of an emollient, V0034CR cream, and its active ingredients, to restore the cutaneous barrier. Secondary objectives included assessment of the moisturizing activity of each product and tolerance. The study was not designed to evaluate therapeutic benefit. METHODS: In this randomized, double-blind, 4-arm crossover, clinical pharmacology study, the full emollient V0034CR, its vehicle formulation alone, or with glycerol, or petrolatum, was applied to the forearms of healthy volunteers (n = 51) with dry skin (Kligman score of 2 or 3). Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry were serially measured for 12 hours following application. An analysis of variance with repeated measures was performed on the evolution of TEWL and corneometry. RESULTS: V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001). CONCLUSIONS: The emollient V0034CR presented combined effects, with the petrolatum component improving skin barrier function, with a reduction in TEWL, and the glycerol component improving skin hydration.