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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Device: F# 10495-053; Device: F# 11054-010

• Registration Number: NCT00886587
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Brief 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2014-06-04
• Disposition First Submitted QC: 2014-06-04
• Disposition First Posted: 2014-06-18
• Results First Submitted: 2017-01-16
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Results First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Post-menarchal female subjects must have a negative urine pregnancy test
• Willing to provide written informed consent/assent
• Diagnosed as having mild to moderate Atopic Dermatitis (AD)
• Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
• Willing to replace their body wash and/or soaps with the one provided in this trial

Exclusion Criteria

• Severe AD as determined by the Rajka-Langeland Severity Index
• AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
• History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
• Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
• Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10495-053	F# 10495-053	F# 10495-053 Atopiclair
11054-010	F# 11054-010	F# 11054-010 Investigational Device

Primary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline	Baseline to Day 43	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).

Secondary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline	Baseline to Day 15	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline	Baseline to Day 43	The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Itch Score on Day 43 - Change From Baseline	Baseline to Day 43	The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.

Trial Locations

Locations (2)

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Thomas J. Stephens & Associates, Inc; 🇺🇸 Colorado Springs, Colorado, United States