Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash; Other: Cetaphil® Restoraderm® body wash

• Registration Number: NCT02589392
• Lead Sponsor: Galderma R&D

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

Study Timeline

• Study Start: 2015-05-29
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Primary Completion: 2016-02-03
• Study Completion: 2016-02-03
• Results First Submitted: 2018-02-15
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Results First Posted: 2024-02-26
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moisturizer + Body wash	Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash	Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Body wash	Cetaphil® Restoraderm® body wash	Cetaphil® Restoraderm® body wash (1/day)

Primary Outcome Measures

Name	Time	Method
Time to Relapse (Quantile 25%)	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.

Trial Locations

Locations (8)

Jose R. Reyes Memorial Medical Center; 🇵🇭 Manila, Philippines

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

Hunan Children's Hospital; 🇨🇳 Hunan, Hunan, China

XinHua Hospital; 🇨🇳 Yangpu, Shanghai, China

Department of Dermatology /Beijing Children's Hospital; 🇨🇳 Beijing, XI Cheng, China

Philippine General Hospital; 🇵🇭 Manila, Ermita, Philippines

Asian Hospital and Medical Center; 🇵🇭 Manila, Muntinlupa City, Philippines

St. Luke's Medical Center; 🇵🇭 Taguig, Taguig City, Philippines