Emollients in the Management of Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: glycerol, paraffin (liquid and white soft)
* Device: Atopiclair®
* Drug: Locatop@
* Drug: Locapred@


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 2<br>Active control arm, Locatop@, Locapred@ | Device: Atopiclair®<br>* 1 application in the morning, in the afternoon and in the evening<br>Drug: Locatop@<br>* During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days<br>Drug: Locapred@<br>* During the 3 months study treatment: 1 application in the evening in case of flare <br>|
| Other: Group 3<br>Absence of emollient treatment, Locatop@, Locapred@ | Drug: Locatop@<br>* During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days<br>Drug: Locapred@<br>* During the 3 months study treatment: 1 application in the evening in case of flare <br>|
| Experimental: Group 1<br>glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@ | Drug: glycerol, paraffin (liquid and white soft)<br>* 1 application in the morning and in the evening<br>* Other names: Dexeryl®;Drug: Locatop@<br>* During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days<br>Drug: Locapred@<br>* During the 3 months study treatment: 1 application in the evening in case of flare <br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticosteroid, flare, xerosis, dry skin, dermatitis, eczema, emollient