Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589392
• Other study ID #: RD.03.SPR.29110
• Status: Completed
• Phase: N/A
• Start date: May 29, 2015
• Est. completion date: February 3, 2016

Study information

• Verified date: February 2024
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 3, 2016
• Est. primary completion date: February 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash

• Cetaphil® Restoraderm® body wash

Locations

Country	Name	City	State
China	Department of Dermatology /Beijing Children's Hospital	Beijing	XI Cheng
China	Hunan Children's Hospital	Hunan	Hunan
China	Department of Dermatology /Shenzhen Children's hospital	Shenzhen	Guangdong
China	XinHua Hospital	Yangpu	Shanghai
Philippines	Asian Hospital and Medical Center	Manila	Muntinlupa City
Philippines	Jose R. Reyes Memorial Medical Center	Manila
Philippines	Philippine General Hospital	Manila	Ermita
Philippines	St. Luke's Medical Center	Taguig	Taguig City

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

China,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Relapse (Quantile 25%)	Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.	The duration between Baseline and the first AD relapse occurred (up to 89 days)