Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Condition(s) targeted: Atopic Dermatitis

Intervention: V0034CR01B (Drug); Vehicle cream (Drug); desonide 0.1% cream (Drug); Foaming gel (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pierre Fabre Medicament

Official(s) and/or principal investigator(s):
Franck BORALEVI, Pr, Principal Investigator, Affiliation: Health centre

Overall contact:
Pierre Fabre Medicament, Email: contact_essais_cliniques@pierre-fabre.com

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.

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

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

Secondary outcome:

Hydration Index score : measurement of the skin hydration

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

Xerosis Visual Analogue Scale (evaluation skin dryness)

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

Overall assessment of treatment efficacy by the investigator

Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)

Assessment of the local tolerability and the systemic safety (reported adverse events)

Topical corticosteroid assessment

Minimum age: 2 Years. Maximum age: 6 Years. Gender(s): Both.

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

Pierre Fabre Medicament, Email: contact_essais_cliniques@pierre-fabre.com

Estonia, Tallinn, Estonia; Recruiting

Estonia, Tartu, Estonia; Recruiting

France, Bordeaux, France; Recruiting

France, Martigues, France; Recruiting

France, Nantes, France; Recruiting

France, Nice, France; Recruiting

France, Poitiers, France; Recruiting

Lithuania, Vilnius, Lithuania; Not yet recruiting

Poland, Białystok, Poland; Not yet recruiting

Poland, Inowrocław, Poland; Not yet recruiting

Poland, Oleśnica, Poland; Not yet recruiting

Poland, Poznań, Poland; Not yet recruiting

Poland, Płock, Poland; Not yet recruiting

Poland, Strzelce Opolskie, Poland; Not yet recruiting

Poland, Warszawa, Poland; Not yet recruiting

Poland, Łódź, Poland; Not yet recruiting

Poland, Żyrardów, Poland; Not yet recruiting

Romania, Brasov, Romania; Not yet recruiting

Romania, Bucharest, Romania; Not yet recruiting

Romania, Constanta, Romania; Not yet recruiting

Romania, Craiova, Romania; Not yet recruiting

Romania, Iasi, Romania; Not yet recruiting

Romania, Ploiesti, Romania; Not yet recruiting

Romania, Sibiu, Romania; Not yet recruiting

Romania, Targu Mures, Romania; Not yet recruiting

Starting date: November 2011
Last updated: December 6, 2011