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To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

Atopic Dermatitis Clinical Trial

Official title:
A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

Clinical Trial Summary

The purpose of this study is to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study is being done to see how safe the investigational new study product is and how well it will work to treat AD in children, by making AD visually better, and reducing the amount of itch.

Clinical Trial Description

This is a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects will be screened to ensure that approximately 80 subjects are randomized, to yield 70 completed subjects. Subjects will be randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects will return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products will be used topically during the duration of the study. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00886587
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase N/A
Start date April 2009
Completion date July 2009
View Details
See also
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