Status:
COMPLETED
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-12 years
Phase:
NA
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 (A...
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 appro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00886587
Start Date
April 1 2009
End Date
June 1 2009
Last Update
May 23 2017
Active Locations (2)
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1
Thomas J. Stephens & Associates, Inc
Colorado Springs, Colorado, United States, 80915
2
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106