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Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V0034CR01B
Vehicle cream
desonide 0.1% cream
Foaming gel
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, pruritus, eczema, emollient, corticosteroid

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting with atopic dermatitis, dry skin, objective SCORAD < 15,
  • With xerosis on the body and a xerosis score > = 2 (SCORAD sub-score) on the anterior part of lower limbs,

Exclusion Criteria:

  • Acute phase of atopic dermatitis
  • Severe form of atopic dermatitis

Sites / Locations

  • Estonia
  • Estonia
  • France
  • France
  • France
  • France
  • France
  • Lithuania
  • Poland
  • Poland
  • Poland
  • Poland
  • Poland
  • Poland
  • Poland
  • Poland
  • Poland
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania
  • Romania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V0034CR01B

Vehicle cream

Arm Description

Outcomes

Primary Outcome Measures

Xerosis score: mean evolution over the different time-points of double-blind period

Secondary Outcome Measures

Hydration Index score : measurement of the skin hydration
Xerosis score evolution over the different time-ponts during open label period
Xerosis Visual Analogue Scale (evaluation skin dryness)
Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
Overall assessment of treatment efficacy by the investigator
Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
Assessment of the local tolerability and the systemic safety (reported adverse events)
Topical corticosteroid assessment

Full Information

First Posted
October 24, 2011
Last Updated
February 20, 2013
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT01467362
Brief Title
Efficacy Emollient on Xerosis in Children With Atopic Dermatitis
Official Title
Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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
Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy. The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.

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, pruritus, eczema, emollient, corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V0034CR01B
Arm Type
Experimental
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
V0034CR01B
Intervention Description
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
Intervention Type
Drug
Intervention Name(s)
desonide 0.1% cream
Other Intervention Name(s)
Locapred
Intervention Description
cream, once a day (in the evening) during flares
Intervention Type
Other
Intervention Name(s)
Foaming gel
Other Intervention Name(s)
Pediatril
Intervention Description
for the washing and cleaning
Primary Outcome Measure Information:
Title
Xerosis score: mean evolution over the different time-points of double-blind period
Time Frame
During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)
Secondary Outcome Measure Information:
Title
Hydration Index score : measurement of the skin hydration
Time Frame
Day 1, Day 14, Day 28, Day 56 and Day 84
Title
Xerosis score evolution over the different time-ponts during open label period
Time Frame
At Visit1 (Day 1) and at Day 56 and Day 84
Title
Xerosis Visual Analogue Scale (evaluation skin dryness)
Time Frame
Day 1, Day 14, Day 28, Day 56 and Day 84
Title
Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
Time Frame
Day1, Day 28, Day 56 and Day 84.
Title
Overall assessment of treatment efficacy by the investigator
Time Frame
Day 28 and Day 84
Title
Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
Time Frame
at Day 28 and at Day 84
Title
Assessment of the local tolerability and the systemic safety (reported adverse events)
Time Frame
Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Title
Topical corticosteroid assessment
Time Frame
Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84

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: Presenting with atopic dermatitis, dry skin, objective SCORAD < 15, With xerosis on the body and a xerosis score > = 2 (SCORAD sub-score) on the anterior part of lower limbs, Exclusion Criteria: Acute phase of atopic dermatitis Severe form of atopic dermatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck BORALEVI, Pr
Organizational Affiliation
Health centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Estonia
City
Tallinn
Country
Estonia
Facility Name
Estonia
City
Tartu
Country
Estonia
Facility Name
France
City
Bordeaux
Country
France
Facility Name
France
City
Martigues
Country
France
Facility Name
France
City
Nantes
Country
France
Facility Name
France
City
Nice
Country
France
Facility Name
France
City
Poitiers
Country
France
Facility Name
Lithuania
City
Vilnius
Country
Lithuania
Facility Name
Poland
City
Białystok
Country
Poland
Facility Name
Poland
City
Inowrocław
Country
Poland
Facility Name
Poland
City
Oleśnica
Country
Poland
Facility Name
Poland
City
Poznań
Country
Poland
Facility Name
Poland
City
Płock
Country
Poland
Facility Name
Poland
City
Strzelce Opolskie
Country
Poland
Facility Name
Poland
City
Warszawa
Country
Poland
Facility Name
Poland
City
Łódź
Country
Poland
Facility Name
Poland
City
Żyrardów
Country
Poland
Facility Name
Romania
City
Brasov
Country
Romania
Facility Name
Romania
City
Bucharest
Country
Romania
Facility Name
Romania
City
Constanta
Country
Romania
Facility Name
Romania
City
Craiova
Country
Romania
Facility Name
Romania
City
Iasi
Country
Romania
Facility Name
Romania
City
Ploiesti
Country
Romania
Facility Name
Romania
City
Sibiu
Country
Romania
Facility Name
Romania
City
Targu Mures
Country
Romania

12. IPD Sharing Statement

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Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

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