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A multicenter, randomized, vehicle-controlled clinical study to examine the efficacy and safety of MAS063DP (Atopiclair[TM]) in the management of mild to moderate atopic dermatitis in adults.

Journal of Drugs in Dermatology

| March 01, 2006 | Abramovits, William; Boguniewicz, Mark | COPYRIGHT 2006 Journal of Drugs in Dermatology, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Abstract

Background: MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis.

Design: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US.

Methods: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication.

Results: MAS063DP was statistically (p

Conclusion: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.

Introduction

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