N/A
N=120
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02589392 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Time to Relapse (Quantile 25%) — 48; 15 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash (Other); Cetaphil® Restoraderm® body wash (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse (Quantile 25%) |
48; 15 | — |
Summary
The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.
Eligibility Criteria
Inclusion Criteria
- Male or female subject, aged 2 to 12 years inclusive
- Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.
Exclusion Criteria
- Subject presenting bacterial, viral, fungal or parasite skin infection
- Subject with ulcerated lesions, acne or rosacea
- Immunosuppression
- Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor
- Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid
- Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators
Data sourced from ClinicalTrials.gov (NCT02589392). 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.