Emollients in the Management of Atopic Dermatitis

Pierre Fabre Medicament347 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

347

Conditions

Atopic Dermatitis

Interventions

glycerol, paraffin (liquid and white soft)DRUG

1 application in the morning and in the evening

Atopiclair®DEVICE

1 application in the morning, in the afternoon and in the evening

Locatop@DRUG

During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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,

Locations (15)

Unnamed facility

Tallinn, Estonia

Unnamed facility

Tartu, Estonia

Unnamed facility

Bordeaux, France

Unnamed facility

Poitiers, France

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks of treatment.

Data from ClinicalTrials.gov

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