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A double‐blind, randomized, vehicle‐controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIR TM ) in the management of atopic dermatitis in paediatric patients

A double‐blind, randomized, vehicle‐controlled clinical study to evaluate the efficacy and safety... A multicenter, randomized, double‐blind, vehicle‐controlled clinical study was conducted to evaluate the efficacy and safety of MAS063DP in 60 paediatric patients affected by atopic dermatitis (AD), aged between 2 and 17 years. Using the Investigator’s Global Assessment (IGA) score for AD, patients with a score of 2 (mild) or 3 (moderate) were enrolled in the study. Patients were randomly selected to receive MAS063DP (20 patients), MAS060 (20 patients, a similar formulation with lower key ingredients’ concentration and no preservatives) or vehicle (20 patients).The study consisted in a treatment period of 43 days, with clinical evaluations at baseline (day 1), days 8, 15, 22, 29 and 43, at which time the treatment was stopped. MAS063DP showed nearly 80% improvement in IGA score at day 22, compared with 16.6% and 26.3% with the MAS060 and vehicle respectively. A statistically significant difference was found by comparing MAS063DP with MAS060 (p < 0.0001); a similar result was evidenced comparing MAS063DP and vehicle (p = 0.001). By contrast, no significant difference was found between MAS060 and vehicle. A statistically significant difference was sustained until the end of the study. MAS063DP may therefore be considered as one of the available regimens effective in the treatment of mild‐to‐moderate AD in children and adolescents. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pediatric Allergy and Immunology Wiley

A double‐blind, randomized, vehicle‐controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIR TM ) in the management of atopic dermatitis in paediatric patients

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References (20)

Publisher
Wiley
Copyright
© 2008 The Authors. Journal compilation © 2008 Blackwell Munksgaard
ISSN
0905-6157
eISSN
1399-3038
DOI
10.1111/j.1399-3038.2008.00724.x
pmid
18298424
Publisher site
See Article on Publisher Site

Abstract

A multicenter, randomized, double‐blind, vehicle‐controlled clinical study was conducted to evaluate the efficacy and safety of MAS063DP in 60 paediatric patients affected by atopic dermatitis (AD), aged between 2 and 17 years. Using the Investigator’s Global Assessment (IGA) score for AD, patients with a score of 2 (mild) or 3 (moderate) were enrolled in the study. Patients were randomly selected to receive MAS063DP (20 patients), MAS060 (20 patients, a similar formulation with lower key ingredients’ concentration and no preservatives) or vehicle (20 patients).The study consisted in a treatment period of 43 days, with clinical evaluations at baseline (day 1), days 8, 15, 22, 29 and 43, at which time the treatment was stopped. MAS063DP showed nearly 80% improvement in IGA score at day 22, compared with 16.6% and 26.3% with the MAS060 and vehicle respectively. A statistically significant difference was found by comparing MAS063DP with MAS060 (p < 0.0001); a similar result was evidenced comparing MAS063DP and vehicle (p = 0.001). By contrast, no significant difference was found between MAS060 and vehicle. A statistically significant difference was sustained until the end of the study. MAS063DP may therefore be considered as one of the available regimens effective in the treatment of mild‐to‐moderate AD in children and adolescents.

Journal

Pediatric Allergy and Immunology – Wiley

Published: Nov 1, 2008

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