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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT02589392 |
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Date of registration:
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23/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
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Scientific title:
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Effect of Cetaphil® Restoraderm® Moisturizer on Very Dry Skin in Children With a Controlled Atopic Dermatitis:a Randomised, Parallel Group Study |
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Date of first enrolment:
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May 29, 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02589392 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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China
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Philippines
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Other: Cetaphil® Restoraderm® body wash
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Other: Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
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Primary Outcome(s)
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Time to Relapse (Quantile 25%)
[Time Frame: The duration between Baseline and the first AD relapse occurred (up to 89 days)]
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Secondary ID(s)
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RD.03.SPR.29110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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