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

Annalisa Patrizi, Bruno Capitanio, Iria Neri, Federica Giacomini, Jo L. Sinagra, Beatrice Raone, Enzo Berardesca

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)619-625
Number of pages7
JournalPediatric Allergy and Immunology
Volume19
Issue number7
DOIs
Publication statusPublished - Nov 2008

Keywords

  • Atopic dermatitis
  • Atopiclair
  • Investigator's Global Assesment
  • MAS063DP
  • Paediatric patients

ASJC Scopus subject areas

  • Immunology and Allergy
  • Pediatrics, Perinatology, and Child Health
  • Immunology

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