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
1 other identifier
interventional
82
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 23, 2017
CompletedMay 23, 2017
April 1, 2017
2 months
April 22, 2009
January 16, 2017
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
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).
Baseline to Day 43
Secondary Outcomes (3)
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
Baseline to Day 15
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
Baseline to Day 43
Itch Score on Day 43 - Change From Baseline
Baseline to Day 43
Study Arms (2)
11054-010
EXPERIMENTALF# 11054-010 Investigational Device
10495-053
ACTIVE COMPARATORF# 10495-053 Atopiclair
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Thomas J. Stephens & Associates, Inc
Colorado Springs, Colorado, 80915, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amisha Parikh-Das, PhD/Study Director
- Organization
- Johnson & Johnson Consumer Inc
Study Officials
- STUDY DIRECTOR
Qing Li, PhD
Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 23, 2017
Results First Posted
May 23, 2017
Record last verified: 2017-04