Emollients in the Management of Atopic Dermatitis

February 18, 2014 updated by: Pierre Fabre Medicament

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
  • France
      • Bordeaux, France
      • Poitiers, France
  • Lithuania
      • Vilnius, Lithuania
  • Poland
      • Pruszków, Poland
      • Płock, Poland
      • Warszawa, Poland
      • Łódź, Poland
  • Romania
      • Braşov, Romania
      • Bucharest, Romania
      • Craiova, Romania
      • Iaşi, Romania
      • Sibiu, Romania
      • Targu Mureş, Romania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 2
Active control arm, Locatop@, Locapred@
Device: Atopiclair®
1 application in the morning, in the afternoon and in the evening
Drug: Locatop@

During the Run-In period:

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

Drug: Locapred@

During the 3 months study treatment:

1 application in the evening in case of flare "
Other: Group 3
Absence of emollient treatment, Locatop@, Locapred@
Drug: Locatop@

During the Run-In period:

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

Drug: Locapred@

During the 3 months study treatment:

1 application in the evening in case of flare "
Experimental: Group 1

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

, Locapred@
Drug: Locatop@

During the Run-In period:

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

Drug: Locapred@

During the 3 months study treatment:

1 application in the evening in case of flare "

Drug: glycerol, paraffin (liquid and white soft)
1 application in the morning and in the evening
Other Names:
  • Dexeryl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with at least one flare over the treatment period
Time Frame: 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).
12 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V00034 CR 3 13 1B
  • 2012-004621-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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