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Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
Cetaphil® Restoraderm® body wash
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Children's Hospital
  • Children's hospital
  • Hunan Children's Hospital
  • XinHua Hospital
  • Asian Hospital and Medical Center
  • Jose R. Reyes Memorial Medical Center
  • Philippine General Hospital
  • St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moisturizer + Body wash

Body wash

Arm Description

Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)

Cetaphil® Restoraderm® body wash (1/day)

Outcomes

Primary Outcome Measures

Time to relapse

Secondary Outcome Measures

Full Information

First Posted
October 23, 2015
Last Updated
March 1, 2016
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02589392
Brief Title
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Official Title
Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moisturizer + Body wash
Arm Type
Experimental
Arm Description
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Arm Title
Body wash
Arm Type
Active Comparator
Arm Description
Cetaphil® Restoraderm® body wash (1/day)
Intervention Type
Other
Intervention Name(s)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
Intervention Type
Other
Intervention Name(s)
Cetaphil® Restoraderm® body wash
Primary Outcome Measure Information:
Title
Time to relapse
Time Frame
The duration between Baseline and the first AD relapse occurs (from randomization to last visit at 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Beijing Children's Hospital
City
Xi Cheng District
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Children's hospital
City
Shenzhen city
State/Province
Guangdong
ZIP/Postal Code
518026
Country
China
Facility Name
Hunan Children's Hospital
City
Hunan
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
XinHua Hospital
City
Yangpu
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Asian Hospital and Medical Center
City
Manila
State/Province
Muntinlupa City
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Jose R. Reyes Memorial Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Philippine General Hospital
City
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Taguig City
ZIP/Postal Code
1634
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
29143926
Citation
Ma L, Li P, Tang J, Guo Y, Shen C, Chang J, Kerrouche N. Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer. Adv Ther. 2017 Dec;34(12):2601-2611. doi: 10.1007/s12325-017-0640-6. Epub 2017 Nov 16.
Results Reference
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Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

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