TY - JOUR
T1 - MAS063DP is Effective Monotherapy for Mild to Moderate Atopic Dermatitis in Infants and Children
T2 - A Multicenter, Randomized, Vehicle-Controlled Study
AU - Boguniewicz, Mark
AU - Zeichner, Joshua A.
AU - Eichenfield, Lawrence F.
AU - Hebert, Adelaide A.
AU - Jarratt, Michael
AU - Lucky, Anne W.
AU - Paller, Amy S.
N1 - Funding Information:
This work was sponsored by Sinclair Pharmaceuticals Ltd (Surrey, UK).
Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2008/6
Y1 - 2008/6
N2 - Objective: To examine the efficacy and safety of MAS063DP (Atopiclair) cream in the management of mild to moderate atopic dermatitis in infants and children. Study design: 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. Conclusion: MAS063DP cream is effective and safe as monotherapy for the treatment of symptoms of mild to moderate atopic dermatitis in infants and children.
AB - Objective: To examine the efficacy and safety of MAS063DP (Atopiclair) cream in the management of mild to moderate atopic dermatitis in infants and children. Study design: 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. Conclusion: MAS063DP cream is effective and safe as monotherapy for the treatment of symptoms of mild to moderate atopic dermatitis in infants and children.
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U2 - 10.1016/j.jpeds.2007.11.031
DO - 10.1016/j.jpeds.2007.11.031
M3 - Article
C2 - 18492531
AN - SCOPUS:43549098591
SN - 0022-3476
VL - 152
SP - 854
EP - 859
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 6
ER -