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

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<.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.

• Authors: William Abramovits, Mark Boguniewicz, Adult Atopiclair Study Group
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 5 Issue 3 Pg. 236-44 (Mar 2006) ISSN: 1545-9616 [Print] United States
• PMID: 16573256 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Dermatologic Agents
• Drug Combinations
• Plant Extracts
• Thiazoles
• Thiazolidines
• telmesteine
• Hyaluronic Acid
• Glycyrrhetinic Acid

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
• Colorado
• Dermatitis, Atopic (drug therapy, pathology)
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Glycyrrhetinic Acid (therapeutic use)
• Humans
• Hyaluronic Acid (therapeutic use)
• Male
• Middle Aged
• Plant Extracts (therapeutic use)
• Severity of Illness Index
• Texas
• Thiazoles (therapeutic use)
• Thiazolidines
• Treatment Outcome
• Vitis (chemistry)