Clinical trial NCT02589392: Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Official title: Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Time to Relapse (Quantile 25%)
timeFrame: The duration between Baseline and the first AD relapse occurred (up to 89 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Department of Dermatology /Shenzhen Children's hospital
state: Guangdong
city: Hunan
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Yangpu
country: China
facility: XinHua Hospital
state: Shanghai
city: Beijing
country: China
facility: Department of Dermatology /Beijing Children's Hospital
state: XI Cheng
city: Manila
country: Philippines
facility: Philippine General Hospital
state: Ermita
city: Manila
country: Philippines
facility: Asian Hospital and Medical Center
state: Muntinlupa City
city: Taguig
country: Philippines
facility: St. Luke's Medical Center
state: Taguig City
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
Study officials:
References:
citation: Ma L, Li P, Tang J, Guo Y, Shen C, Chang J, Kerrouche N. Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer. Adv Ther. 2017 Dec;34(12):2601-2611. doi: 10.1007/s12325-017-0640-6. Epub 2017 Nov 16.