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

35 Citations (Scopus)

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

Fingerprint

Atopic Dermatitis
Pediatrics
Safety
Research Personnel
MAS063DP
Clinical Studies
Therapeutics

Keywords

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

ASJC Scopus subject areas

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

Cite this

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

In: Pediatric Allergy and Immunology, Vol. 19, No. 7, 11.2008, p. 619-625.

Research output: Contribution to journalArticle

@article{96ca8cf58f324f81a15ba2bd7eadc07b,
title = "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.",
keywords = "Atopic dermatitis, Atopiclair, Investigator's Global Assesment, MAS063DP, Paediatric patients",
author = "Annalisa Patrizi and Bruno Capitanio and Iria Neri and Federica Giacomini and Sinagra, {Jo L.} and Beatrice Raone and Enzo Berardesca",
year = "2008",
month = "11",
doi = "10.1111/j.1399-3038.2008.00724.x",
language = "English",
volume = "19",
pages = "619--625",
journal = "Pediatric Allergy and Immunology",
issn = "0905-6157",
publisher = "Blackwell Munksgaard",
number = "7",

}

TY - JOUR

T1 - 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

AU - Patrizi, Annalisa

AU - Capitanio, Bruno

AU - Neri, Iria

AU - Giacomini, Federica

AU - Sinagra, Jo L.

AU - Raone, Beatrice

AU - Berardesca, Enzo

PY - 2008/11

Y1 - 2008/11

N2 - 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.

AB - 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.

KW - Atopic dermatitis

KW - Atopiclair

KW - Investigator's Global Assesment

KW - MAS063DP

KW - Paediatric patients

UR - http://www.scopus.com/inward/record.url?scp=46649088270&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=46649088270&partnerID=8YFLogxK

U2 - 10.1111/j.1399-3038.2008.00724.x

DO - 10.1111/j.1399-3038.2008.00724.x

M3 - Article

C2 - 18298424

AN - SCOPUS:46649088270

VL - 19

SP - 619

EP - 625

JO - Pediatric Allergy and Immunology

JF - Pediatric Allergy and Immunology

SN - 0905-6157

IS - 7

ER -