Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

February 12, 2024 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518026
        • Department of Dermatology /Shenzhen Children's hospital
    • Hunan
      • Hunan, Hunan, China, 410007
        • Hunan Children's Hospital
    • Shanghai
      • Yangpu, Shanghai, China, 200092
        • Xinhua Hospital
    • XI Cheng
      • Beijing, XI Cheng, China, 100045
        • Department of Dermatology /Beijing Children's Hospital
  • Philippines
      • Manila, Philippines, 1003
        • Jose R. Reyes Memorial Medical Center
    • Ermita
      • Manila, Ermita, Philippines, 1000
        • Philippine General Hospital
    • Muntinlupa City
      • Manila, Muntinlupa City, Philippines, 1780
        • Asian Hospital and Medical Center
    • Taguig City
      • Taguig, Taguig City, Philippines, 1634
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moisturizer + Body wash
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
Active Comparator: Body wash
Cetaphil® Restoraderm® body wash (1/day)
Other: Cetaphil® Restoraderm® body wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The duration between Baseline and the first AD relapse occurred (up to 89 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2015

Primary Completion (Actual)

February 3, 2016

Study Completion (Actual)

February 3, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimated)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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