Emollients in the Management of Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: glycerol, paraffin (liquid and white soft); Device: Atopiclair®; Drug: Locatop@; Drug: Locapred@

• Registration Number: NCT01779258
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Study Start: 2013-02
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Locatop@	Active control arm, Locatop@, Locapred@
Group 2	Locapred@	Active control arm, Locatop@, Locapred@
Group 3	Locatop@	Absence of emollient treatment, Locatop@, Locapred@
Group 3	Locapred@	Absence of emollient treatment, Locatop@, Locapred@
Group 1	glycerol, paraffin (liquid and white soft)	glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@
Group 1	Locatop@	glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@
Group 1	Locapred@	glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@
Group 2	Atopiclair®	Active control arm, Locatop@, Locapred@

Primary Outcome Measures

Name	Time	Method
Percentage of patients with at least one flare over the treatment period	12 weeks of treatment.	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).