NCT00886587

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was 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 was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.

Detailed description

This was 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 were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J\&J Device or Atopiclair®. All subjects were to 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 were used topically during the duration of the study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	F# 11054-010	Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.
DEVICE	F# 10495-053	Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-04-23
• Last updated: 2017-05-23
• Results posted: 2017-05-23

Locations

2 sites across 1 country: United States