Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

NCT01467362 | Completed Phase 3

• 2 other identifiers: V00034 CR 3 12 1B2011-003295-37
• Study Type: interventional
• Target: 251
• Locations: 5 countries
• Sites: 25

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.

Conditions

Atopic Dermatitis

Keywords

xerosis; dry skin; dermatitis; pruritus; eczema; emollient; corticosteroid

Outcome Measures

Primary Outcomes (1)

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

  During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)

Secondary Outcomes (8)

• Hydration Index score : measurement of the skin hydration

  Day 1, Day 14, Day 28, Day 56 and Day 84

• Xerosis score evolution over the different time-ponts during open label period

  At Visit1 (Day 1) and at Day 56 and Day 84

• Xerosis Visual Analogue Scale (evaluation skin dryness)

  Day 1, Day 14, Day 28, Day 56 and Day 84

• Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.

  Day1, Day 28, Day 56 and Day 84.

• Overall assessment of treatment efficacy by the investigator

  Day 28 and Day 84

Study Arms (2)

V0034CR01B

EXPERIMENTAL

Drug: V0034CR01B; Drug: desonide 0.1% cream; Other: Foaming gel

Vehicle cream

PLACEBO COMPARATOR

Drug: Vehicle cream; Drug: desonide 0.1% cream; Other: Foaming gel

Interventions

V0034CR01B DRUG

Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days

V0034CR01B

Vehicle cream DRUG

Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days

Vehicle cream

desonide 0.1% cream DRUG

cream, once a day (in the evening) during flares

Also known as: Locapred

V0034CR01B; Vehicle cream

Foaming gel OTHER

for the washing and cleaning

Also known as: Pediatril

V0034CR01B; Vehicle cream

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (25)

Estonia

Tallinn, Estonia

Location

Estonia

Tartu, Estonia

Location

France

Bordeaux, France

Location

France

Martigues, France

Location

France

Nantes, France

Location

France

Nice, France

Location

France

Poitiers, France

Location

Lithuania

Vilnius, Lithuania

Location

Poland

Bialystok, Poland

Location

Poland

Inowrocław, Poland

Location

Poland

Lodz, Poland

Location

Poland

Oleśnica, Poland

Location

Poland

Poznan, Poland

Location

Poland

Płock, Poland

Location

Poland

Strzelce Opolskie, Poland

Location

Poland

Warsaw, Poland

Location

Poland

Żyrardów, Poland

Location

Romania

Brasov, Romania

Location

Romania

Bucharest, Romania

Location

Romania

Constanța, Romania

Location

Romania

Craiova, Romania

Location

Romania

Iași, Romania

Location

Romania

Ploieşti, Romania

Location

Romania

Sibiu, Romania

Location

Romania

Târgu Mureş, Romania

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Pruritus; Eczema

Interventions

Desonide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Franck BORALEVI, Pr

  Health centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

FR (5); PL (9); RO (8); ES (2); LI (1)