Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
Two groups randomized in a ratio of [1:1] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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