A Multicenter, Randomized, Vehicle-Controlled Clinical Study to Examine the Efficacy and Safety of MAS063DP (Atopiclairâ„¢) in the Management of Mild to Moderate Atopic Dermatitis in Adults
March 2006 | Volume 5 | Issue 3 | Original Article | 236 | Copyright © March 2006
William Abramovits MD, Mark Boguniewicz MD
AbstractBackground: 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<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event.
Conclusion: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.