search
Back to results

Emollients in the Management of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
glycerol, paraffin (liquid and white soft)
Atopiclair®
Locatop@
Locapred@
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring xerosis, dry skin, dermatitis, eczema, emollient, corticosteroid, flare

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept 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,

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Experimental

Arm Label

Group 2

Group 3

Group 1

Arm Description

Active control arm, Locatop@, Locapred@

Absence of emollient treatment, Locatop@, Locapred@

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

Outcomes

Primary Outcome Measures

Percentage of patients with at least one flare over the treatment period
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).

Secondary Outcome Measures

Full Information

First Posted
January 28, 2013
Last Updated
February 18, 2014
Sponsor
Pierre Fabre Medicament
search

1. Study Identification

Unique Protocol Identification Number
NCT01779258
Brief Title
Emollients in the Management of Atopic Dermatitis
Official Title
Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
xerosis, dry skin, dermatitis, eczema, emollient, corticosteroid, flare

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Other
Arm Description
Active control arm, Locatop@, Locapred@
Arm Title
Group 3
Arm Type
Other
Arm Description
Absence of emollient treatment, Locatop@, Locapred@
Arm Title
Group 1
Arm Type
Experimental
Arm Description
glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@
Intervention Type
Drug
Intervention Name(s)
glycerol, paraffin (liquid and white soft)
Other Intervention Name(s)
Dexeryl®
Intervention Description
1 application in the morning and in the evening
Intervention Type
Device
Intervention Name(s)
Atopiclair®
Intervention Description
1 application in the morning, in the afternoon and in the evening
Intervention Type
Drug
Intervention Name(s)
Locatop@
Intervention Description
During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days
Intervention Type
Drug
Intervention Name(s)
Locapred@
Intervention Description
During the 3 months study treatment: 1 application in the evening in case of flare "
Primary Outcome Measure Information:
Title
Percentage of patients with at least one flare over the treatment period
Description
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).
Time Frame
12 weeks of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Facility Information:
City
Tallinn
Country
Estonia
City
Tartu
Country
Estonia
City
Bordeaux
Country
France
City
Poitiers
Country
France
City
Vilnius
Country
Lithuania
City
Pruszków
Country
Poland
City
Płock
Country
Poland
City
Warszawa
Country
Poland
City
Łódź
Country
Poland
City
Braşov
Country
Romania
City
Bucharest
Country
Romania
City
Craiova
Country
Romania
City
Iaşi
Country
Romania
City
Sibiu
Country
Romania
City
Targu Mureş
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

Emollients in the Management of Atopic Dermatitis

We'll reach out to this number within 24 hrs