Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01467362
First received: October 24, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: V0034CR01B
Drug: Vehicle cream
Drug: desonide 0.1% cream
Other: Foaming gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hydration Index score : measurement of the skin hydration [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Xerosis Visual Analogue Scale (evaluation skin dryness) [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
  • Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis. [ Time Frame: Day1, Day 28, Day 56 and Day 84. ] [ Designated as safety issue: No ]
  • Overall assessment of treatment efficacy by the investigator [ Time Frame: Day 28 and Day 84 ] [ Designated as safety issue: No ]
  • Overall assessment of treatment efficacy and use by the parent(s)/guardian(s) [ Time Frame: at Day 28 and at Day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Topical corticosteroid assessment [ Time Frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Locapred
Other: Foaming gel
for the washing and cleaning
Other Name: Pediatril
Placebo Comparator: Vehicle cream 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
Drug: desonide 0.1% cream
cream, once a day (in the evening) during flares
Other Name: Locapred
Other: Foaming gel
for the washing and cleaning
Other Name: Pediatril

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01467362

Locations
Estonia
Estonia
Tallinn, Estonia
Estonia
Tartu, Estonia
France
France
Bordeaux, France
France
Martigues, France
France
Nantes, France
France
Nice, France
France
Poitiers, France
Lithuania
Lithuania
Vilnius, Lithuania
Poland
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
Romania
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
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Principal Investigator: Franck BORALEVI, Pr Health centre
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01467362     History of Changes
Other Study ID Numbers: V00034 CR 3 12 1B, 2011-003295-37
Study First Received: October 24, 2011
Last Updated: February 20, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014