Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology /Shenzhen Children's hospital, Shenzhen, Guangdong, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash

Other

Cetaphil® Restoraderm® body wash

Other

Primary outcomes

Time to Relapse (Quantile 25%)

Time frame: The duration between Baseline and the first AD relapse occurred (up to 89 days)

Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 28, 2015
Registry last updated: Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed