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 Details — Status: Completed

Administrative data

• NCT number: NCT00886587
• Other study ID #: EMOECZ0002
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: June 4, 2014
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: June 2014
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 (See Topical Corticosteroid Potency Chart in Section 5.6). 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

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Thomas J. Stephens & Associates, Inc	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI score		at Day 43	No
Secondary	EASI score		at Day 15	No
Secondary	IGADA of therapy		at Day 43	No
Secondary	Subject's and/or caregiver's assessment of itch, on a 10-cm VAS		at Day 43	No