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


METHODS
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.


CONCLUSIONS
MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.
Department of Dermatology, Baylor University Medical Center, USA.
William
W
Abramovits
Mark
M
Boguniewicz
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003120:Colorado; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006034:Glycyrrhetinic Acid / Q000627:therapeutic use*; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use; D012720:Severity of Illness Index; D013781:Texas; D013844:Thiazoles / Q000627:therapeutic use*; D053778:Thiazolidines; D016896:Treatment Outcome; D027843:Vitis / Q000737:chemistry
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D004338:Drug Combinations; D010936:Plant Extracts; D013844:Thiazoles; D053778:Thiazolidines; C091508:telmesteine; D006820:Hyaluronic Acid; D006034:Glycyrrhetinic Acid