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Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589392
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash Other: Cetaphil® Restoraderm® body wash Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Cetaphil

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



Primary Outcome Measures :
  1. Time to relapse [ Time Frame: The duration between Baseline and the first AD relapse occurs (from randomization to last visit at 12 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589392


Locations
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China, Beijing
Beijing Children's Hospital
Xi Cheng District, Beijing, China, 100045
China, Guangdong
Children's hospital
Shenzhen city, Guangdong, China, 518026
China, Hunan
Hunan Children's Hospital
Hunan, Hunan, China, 410007
China, Shanghai
XinHua Hospital
Yangpu, Shanghai, China, 200092
Philippines
Asian Hospital and Medical Center
Manila, Muntinlupa City, Philippines, 1780
Jose R. Reyes Memorial Medical Center
Manila, Philippines, 1003
Philippine General Hospital
Metro Manila, Philippines, 1000
St. Luke's Medical Center
Taguig City, Philippines, 1634
Sponsors and Collaborators
Galderma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02589392    
Other Study ID Numbers: RD.03.SPR.29110
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases