Emollients in the Management of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01779258
First received: January 28, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: glycerol, paraffin (liquid and white soft)
Device: Atopiclair®
Drug: Locatop@
Drug: Locapred@
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Percentage of patients with at least one flare over the treatment period [ Time Frame: 12 weeks of treatment. ] [ Designated as safety issue: No ]
    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).


Enrollment: 347
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 "

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: glycerol, paraffin (liquid and white soft)
1 application in the morning and in the evening
Other Name: Dexeryl®
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 "


  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779258

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
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01779258     History of Changes
Other Study ID Numbers: V00034 CR 3 13 1B, 2012-004621-24
Study First Received: January 28, 2013
Last Updated: February 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Comité de Protection des Personnes
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Lithuania: State Medicine Control Agency - Ministry of Health
Lithuania: Bioethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Estonia: The State Agency of Medicine
Estonia: Research Ethics Committee

Keywords provided by Pierre Fabre Medicament:
xerosis
dry skin
dermatitis
eczema
emollient
corticosteroid
flare

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desonide
Emollients
Glycerol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014