Emollients in the Management of Atopic Dermatitis

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Locatop@; Device: Atopiclair®; Drug: Locapred@; Drug: glycerol, paraffin (liquid and white soft)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01779258

V00034 CR 3 13 1B

2012-004621-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 3 patient groups

Group 2

Other group

Description:

Active control arm, Locatop@, Locapred@

Treatment:

Drug: Locatop@

Drug: Locapred@

Device: Atopiclair®

Group 3

Other group

Description:

Absence of emollient treatment, Locatop@, Locapred@

Treatment:

Drug: Locatop@

Drug: Locapred@

Group 1

Experimental group

Description:

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

Treatment:

Drug: glycerol, paraffin (liquid and white soft)

Drug: Locatop@

Drug: Locapred@