Zoe Diana Draelos1. 1. Department of Dermatology, Duke University School of Medicine, Durham, 2444 North Main Street, High Point, NC 27262, USA. zdraelos@northstate.net
Abstract
BACKGROUND: A variety of prescription devices have been developed to improve barrier function in persons with atopic dermatitis. These products are based primarily on the use of occlusive agents to decrease transepidermal water loss, creating an environment for optimal healing. AIM: A newly developed hyaluronic acid based, pH neutral foam technology formulated to maximize humectancy and normalize transepidermal waster loss was evaluated for its ability to optimize barrier function while minimizing unnecessary irritation. METHODS: This double blind split body study enrolled 20 subjects with mild to moderate symmetrical atopic dermatitis involving body surface area greater than or equal to 10% using the arms or the legs as the target site. Subjects were randomized to apply the hyaluronic acid based emollient foam or the reference ceramide-containing emulsion cream to one side of the body with the other test product applied to the opposite side. Subject and investigator ratings were made for erythema, scaling, lichenification, excoriation, itching, stinging, and burning at baseline, week 2, and week 4. RESULTS: Both formulations achieved statistically significant improvement in all clinical signs and symptoms of atopic dermatitis by week 4, however the hyaluronic acid foam achieved statistically significant improvement in overall eczema severity by week 2, whereas the ceramide-containing emulsion cream did not. The subject's preference statistically significantly favored the foam in terms of ability to spread, moisturize, ease of use, and lack of odor. In addition, the foam was preferred for effectiveness and ability to soothe. CONCLUSION: A prescription hyaluronic acid based foam device offers an aesthetic formulation with excellent efficacy in patients requiring an environment for barrier repair with mild to moderate atopic dermatitis.
RCT Entities:
BACKGROUND: A variety of prescription devices have been developed to improve barrier function in persons with atopic dermatitis. These products are based primarily on the use of occlusive agents to decrease transepidermal water loss, creating an environment for optimal healing. AIM: A newly developed hyaluronic acid based, pH neutral foam technology formulated to maximize humectancy and normalize transepidermal waster loss was evaluated for its ability to optimize barrier function while minimizing unnecessary irritation. METHODS: This double blind split body study enrolled 20 subjects with mild to moderate symmetrical atopic dermatitis involving body surface area greater than or equal to 10% using the arms or the legs as the target site. Subjects were randomized to apply the hyaluronic acid based emollient foam or the reference ceramide-containing emulsion cream to one side of the body with the other test product applied to the opposite side. Subject and investigator ratings were made for erythema, scaling, lichenification, excoriation, itching, stinging, and burning at baseline, week 2, and week 4. RESULTS: Both formulations achieved statistically significant improvement in all clinical signs and symptoms of atopic dermatitis by week 4, however the hyaluronic acid foam achieved statistically significant improvement in overall eczema severity by week 2, whereas the ceramide-containing emulsion cream did not. The subject's preference statistically significantly favored the foam in terms of ability to spread, moisturize, ease of use, and lack of odor. In addition, the foam was preferred for effectiveness and ability to soothe. CONCLUSION: A prescription hyaluronic acid based foam device offers an aesthetic formulation with excellent efficacy in patients requiring an environment for barrier repair with mild to moderate atopic dermatitis.
Authors: Mark G Lebwohl; James Q Del Rosso; William Abramovits; Brian Berman; David E Cohen; Emma Guttman; Anthony J Mancini; Lawrence A Schachner Journal: J Clin Aesthet Dermatol Date: 2013-07