Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Last updated: February 12, 2024
Sponsor: Galderma R&D
Overall Status: Completed

Phase

N/A

Condition

Atopic Dermatitis

Allergy

Eczema (Atopic Dermatitis)

Treatment

Cetaphil® Restoraderm® body wash

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

Clinical Study ID

NCT02589392
RD.03.SPR.29110
  • Ages 2-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subject, aged 2 to 12 years inclusive
  • Controlled mild to moderate atopic dermatitis with a Investigator Global Assessmentscore at 0 or 1, within one week after successful treatment with topicalcorticosteroid.

Exclusion

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 daysfor Calcineurin inhibitor
  • Subject with a wash-out period from baseline for topical treatment more than 8 daysfor corticosteroid
  • Subject with a wash-out period from baseline for systemic treatment less than 8 daysfor anti-histamines, less than 4 weeks for immunomodulators

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Cetaphil® Restoraderm® body wash
Phase:
Study Start date:
May 29, 2015
Estimated Completion Date:
February 03, 2016

Study 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

Connect with a study center

  • Department of Dermatology /Shenzhen Children's hospital

    Shenzhen, Guangdong 518026
    China

    Site Not Available

  • Hunan Children's Hospital

    Hunan, Hunan 410007
    China

    Site Not Available

  • XinHua Hospital

    Yangpu, Shanghai 200092
    China

    Site Not Available

  • Department of Dermatology /Beijing Children's Hospital

    Beijing, XI Cheng 100045
    China

    Site Not Available

  • Philippine General Hospital

    Manila, Ermita 1000
    Philippines

    Site Not Available

  • Asian Hospital and Medical Center

    Manila, Muntinlupa City 1780
    Philippines

    Site Not Available

  • St. Luke's Medical Center

    Taguig, Taguig City 1634
    Philippines

    Site Not Available

  • Jose R. Reyes Memorial Medical Center

    Manila, 1003
    Philippines

    Site Not Available

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