Atopic Dermatitis Clinical Trial
Official title:
Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
Status | Completed |
Enrollment | 347 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Age between 2 and 6 years included, - Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is [15-40] at inclusion), - After treatment of the current flare, patients should have for randomization an Objective SCORAD score < 15, with Xerosis intensity= 1 and no subjective signs Exclusion Criteria: - Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation, - Primary bacterial, viral, fungal or parasitic skin infection, - Ulcerated lesions, acne or rosacea, - Dermatological disease other than atopic dermatitis which could interfere with the assessment, - Immunosuppression, |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pierre Fabre Medicament |
Estonia, France, Lithuania, Poland, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with at least one flare over the treatment period | A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (> 25%) or to the introduction of a new line of therapy(topical corticosteroid). | 12 weeks of treatment. | No |
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