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.

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.

• Authors: Annalisa Patrizi, Bruno Capitanio, Iria Neri, Federica Giacomini, Jo L Sinagra, Beatrice Raone, Enzo Berardesca
• Journal: Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology (Pediatr Allergy Immunol) Vol. 19 Issue 7 Pg. 619-25 (Nov 2008) ISSN: 1399-3038 [Electronic] England
• PMID: 18298424 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dietary Fats
• MAS063DP
• Pharmaceutical Vehicles
• Plant Extracts
• Glycyrrhetinic Acid

Topics

• Adolescent
• Child
• Child, Preschool
• Dermatitis, Atopic (drug therapy, immunology)
• Dietary Fats (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Glycyrrhetinic Acid (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Pharmaceutical Vehicles (administration & dosage, adverse effects, therapeutic use)
• Plant Extracts (administration & dosage, adverse effects, therapeutic use)