Efficacy Emollient on Xerosis in Children With Atopic Dermatitis
This study has been completed.
Sponsor:
Pierre Fabre Medicament
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Desonide Emollients Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013