MAS063DP is effective monotherapy for mild to moderate atopic dermatitis in infants and children: a multicenter, randomized, vehicle-controlled study.
OBJECTIVE
To examine the efficacy and safety of MAS063DP (Atopiclair) cream in the management of mild to moderate atopic dermatitis in infants and children.


METHODS
One hundred forty-two patients aged 6 months to 12 years were administered MAS063DP (n = 72) or vehicle (n = 70) cream 3 times per day to affected areas and sites prone to develop atopic dermatitis. The primary endpoint for efficacy was the Investigator's Global Assessment at day 22. Secondary endpoints included Investigator's Global Assessment at other time-points, patient's/caregiver's assessment of pruritus, onset, duration of itch relief, Eczema Area and Severity Index, subject's/caregiver's assessment of global response, and need for rescue medication in the event of an atopic dermatitis flare.


RESULTS
MAS063DP cream was statistically more effective (P < .0001) than vehicle cream for the primary endpoint and all secondary endpoints. Treatment discontinuation as a result of an adverse event occurred in 9.9% of patients using MAS063DP cream and 16% of patients using vehicle cream.


CONCLUSIONS
MAS063DP cream is effective and safe as monotherapy for the treatment of symptoms of mild to moderate atopic dermatitis in infants and children.
Boguniewicz
Mark
M
Division of Pediatric Allergy-Immunology, Department of Pediatrics, National Jewish Medical and Research Center and University of Colorado School of Medicine, Denver, CO 80206, USA. boguniewiczm@njc.org
Zeichner
Joshua A
JA
Eichenfield
Lawrence F
LF
Hebert
Adelaide A
AA
Jarratt
Michael
M
Lucky
Anne W
AW
Paller
Amy S
AS
D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004041:Dietary Fats / Q000627:therapeutic use*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006034:Glycyrrhetinic Acid / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D014677:Pharmaceutical Vehicles; D010936:Plant Extracts / Q000627:therapeutic use*; D012720:Severity of Illness Index
D004041:Dietary Fats; D004304:Dosage Forms; C530270:MAS063DP; D014677:Pharmaceutical Vehicles; D010936:Plant Extracts; D006034:Glycyrrhetinic Acid