Efficacy Emollient on Xerosis in Children With Atopic Dermatitis
NCT ID: NCT01467362
Last Updated: 2013-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2011-11-30
2012-05-31
Brief Summary
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The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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V0034CR01B
V0034CR01B
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
desonide 0.1% cream
cream, once a day (in the evening) during flares
Foaming gel
for the washing and cleaning
Vehicle cream
Vehicle cream
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
desonide 0.1% cream
cream, once a day (in the evening) during flares
Foaming gel
for the washing and cleaning
Interventions
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V0034CR01B
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Vehicle cream
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
desonide 0.1% cream
cream, once a day (in the evening) during flares
Foaming gel
for the washing and cleaning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With xerosis on the body and a xerosis score \> = 2 (SCORAD sub-score) on the anterior part of lower limbs,
Exclusion Criteria
* Severe form of atopic dermatitis
2 Years
6 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Franck BORALEVI, Pr
Role: PRINCIPAL_INVESTIGATOR
Health centre
Locations
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Estonia
Tallinn, , Estonia
Estonia
Tartu, , Estonia
France
Bordeaux, , France
France
Martigues, , France
France
Nantes, , France
France
Nice, , France
France
Poitiers, , France
Lithuania
Vilnius, , Lithuania
Poland
Bialystok, , Poland
Poland
Inowrocław, , Poland
Poland
Lodz, , Poland
Poland
Oleśnica, , Poland
Poland
Poznan, , Poland
Poland
Płock, , Poland
Poland
Strzelce Opolskie, , Poland
Poland
Warsaw, , Poland
Poland
Żyrardów, , Poland
Romania
Brasov, , Romania
Romania
Bucharest, , Romania
Romania
Constanța, , Romania
Romania
Craiova, , Romania
Romania
Iași, , Romania
Romania
Ploieşti, , Romania
Romania
Sibiu, , Romania
Romania
Târgu Mureş, , Romania
Countries
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Other Identifiers
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2011-003295-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V00034 CR 3 12 1B
Identifier Type: -
Identifier Source: org_study_id
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