N/A
N=82
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00886587 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline — -4.97; -5.01 units on a scale — p=0.9416
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- F# 11054-010 (Device); F# 10495-053 (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline |
-4.97; -5.01 | 0.9416 |
| SECONDARY Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline |
-3.79; -4.14 | 0.5431 |
| SECONDARY Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline |
0.78; 0.73 | 0.788 |
| SECONDARY Itch Score on Day 43 - Change From Baseline |
-3.26; -3.29 | 0.9508 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00886587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.