Emollients in the Management of Atopic Dermatitis

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 2

Active control arm, Locatop@, Locapred@

Group Type OTHER

Atopiclair®

Intervention Type DEVICE

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

Locatop@

Intervention Type DRUG

During the Run-In period:

1 application in the morning and in the evening during a maximum of 21 days

Locapred@

Intervention Type DRUG

During the 3 months study treatment:

1 application in the evening in case of flare "

Group 3

Absence of emollient treatment, Locatop@, Locapred@

Group Type OTHER

Locatop@

Intervention Type DRUG

During the Run-In period:

1 application in the morning and in the evening during a maximum of 21 days

Locapred@

Intervention Type DRUG

During the 3 months study treatment:

1 application in the evening in case of flare "

Group 1

glycerol, paraffin (liquid and white soft), Locatop@

, Locapred@

Group Type EXPERIMENTAL

glycerol, paraffin (liquid and white soft)

Intervention Type DRUG

1 application in the morning and in the evening

Locatop@

Intervention Type DRUG

During the Run-In period:

1 application in the morning and in the evening during a maximum of 21 days

Locapred@

Intervention Type DRUG

During the 3 months study treatment:

1 application in the evening in case of flare "

Interventions

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glycerol, paraffin (liquid and white soft)

1 application in the morning and in the evening

Intervention Type DRUG

Atopiclair®

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

Intervention Type DEVICE

Locatop@

During the Run-In period:

1 application in the morning and in the evening during a maximum of 21 days

Intervention Type DRUG

Locapred@

During the 3 months study treatment:

1 application in the evening in case of flare "

Intervention Type DRUG

Other Intervention Names

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Dexeryl®

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,

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No