Clinical trial NCT01467362: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: xerosis
dry skin
dermatitis
pruritus
eczema
emollient
corticosteroid
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 251
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Xerosis score: mean evolution over the different time-points of double-blind period
timeFrame: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)
Secondary outcomes:
measure: Hydration Index score : measurement of the skin hydration
timeFrame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Xerosis score evolution over the different time-ponts during open label period
timeFrame: At Visit1 (Day 1) and at Day 56 and Day 84
measure: Xerosis Visual Analogue Scale (evaluation skin dryness)
timeFrame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
timeFrame: Day1, Day 28, Day 56 and Day 84.
measure: Overall assessment of treatment efficacy by the investigator
timeFrame: Day 28 and Day 84
measure: Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
timeFrame: at Day 28 and at Day 84
measure: Assessment of the local tolerability and the systemic safety (reported adverse events)
timeFrame: Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
measure: Topical corticosteroid assessment
timeFrame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Estonia
city: Tartu
country: Estonia
facility: Estonia
city: Bordeaux
country: France
facility: France
city: Martigues
country: France
facility: France
city: Nantes
country: France
facility: France
city: Nice
country: France
facility: France
city: Poitiers
country: France
facility: France
city: Vilnius
country: Lithuania
facility: Lithuania
city: Białystok
country: Poland
facility: Poland
city: Inowrocław
country: Poland
facility: Poland
city: Oleśnica
country: Poland
facility: Poland
city: Poznań
country: Poland
facility: Poland
city: Płock
country: Poland
facility: Poland
city: Strzelce Opolskie
country: Poland
facility: Poland
city: Warszawa
country: Poland
facility: Poland
city: Łódź
country: Poland
facility: Poland
city: Żyrardów
country: Poland
facility: Poland
city: Brasov
country: Romania
facility: Romania
city: Bucharest
country: Romania
facility: Romania
city: Constanta
country: Romania
facility: Romania
city: Craiova
country: Romania
facility: Romania
city: Iasi
country: Romania
facility: Romania
city: Ploiesti
country: Romania
facility: Romania
city: Sibiu
country: Romania
facility: Romania
city: Targu Mures
country: Romania
facility: Romania
Study officials:
affiliation: Health centre
name: Franck BORALEVI, Pr
role: PRINCIPAL_INVESTIGATOR
References: