Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

February 20, 2013 updated by: Pierre Fabre Medicament

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

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
        • Estonia
      • Tartu, Estonia
        • Estonia
  • France
      • Bordeaux, France
        • France
      • Martigues, France
        • France
      • Nantes, France
        • France
      • Nice, France
        • France
      • Poitiers, France
        • France
  • Lithuania
      • Vilnius, Lithuania
        • Lithuania
  • Poland
      • Białystok, Poland
        • Poland
      • Inowrocław, Poland
        • Poland
      • Oleśnica, Poland
        • Poland
      • Poznań, Poland
        • Poland
      • Płock, Poland
        • Poland
      • Strzelce Opolskie, Poland
        • Poland
      • Warszawa, Poland
        • Poland
      • Łódź, Poland
        • Poland
      • Żyrardów, Poland
        • Poland
  • Romania
      • Brasov, Romania
        • Romania
      • Bucharest, Romania
        • Romania
      • Constanta, Romania
        • Romania
      • Craiova, Romania
        • Romania
      • Iasi, Romania
        • Romania
      • Ploiesti, Romania
        • Romania
      • Sibiu, Romania
        • Romania
      • Targu Mures, Romania
        • 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

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle cream
Drug: desonide 0.1% cream
cream, once a day (in the evening) during flares
Other Names:
  • Locapred
Other: Foaming gel
for the washing and cleaning
Other Names:
  • Pediatril
Drug: Vehicle cream
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
Experimental: V0034CR01B
Drug: V0034CR01B
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Drug: desonide 0.1% cream
cream, once a day (in the evening) during flares
Other Names:
  • Locapred
Other: Foaming gel
for the washing and cleaning
Other Names:
  • Pediatril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)

Secondary Outcome Measures

Outcome Measure
Time Frame
Hydration Index score : measurement of the skin hydration
Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Day 1, Day 14, Day 28, Day 56 and Day 84
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
At Visit1 (Day 1) and at Day 56 and Day 84
Xerosis Visual Analogue Scale (evaluation skin dryness)
Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Day 1, Day 14, Day 28, Day 56 and Day 84
Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
Time Frame: Day1, Day 28, Day 56 and Day 84.
Day1, Day 28, Day 56 and Day 84.
Overall assessment of treatment efficacy by the investigator
Time Frame: Day 28 and Day 84
Day 28 and Day 84
Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
Time Frame: at Day 28 and at Day 84
at Day 28 and at Day 84
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
Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Topical corticosteroid assessment
Time Frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84

Collaborators and Investigators

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

Sponsor

Pierre Fabre Medicament

Investigators

  • Principal Investigator: Franck BORALEVI, Pr, Health centre

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

November 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V00034 CR 3 12 1B
  • 2011-003295-37 (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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