Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Last updated: February 20, 2013
Sponsor: Pierre Fabre Medicament
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Allergy

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT01467362
V00034 CR 3 12 1B
2011-003295-37
  • Ages 2-6
  • All Genders

Study 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

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 anteriorpart of lower limbs,

Exclusion

Exclusion Criteria:

  • Acute phase of atopic dermatitis

  • Severe form of atopic dermatitis

Study Design

Total Participants: 251
Study Start date:
November 01, 2011
Estimated Completion Date:
May 31, 2012

Connect with a study center

  • Estonia

    Tallinn,
    Estonia

    Site Not Available

  • Estonia

    Tartu,
    Estonia

    Site Not Available

  • France

    Bordeaux,
    France

    Site Not Available

  • France

    Martigues,
    France

    Site Not Available

  • France

    Nantes,
    France

    Site Not Available

  • France

    Nice,
    France

    Site Not Available

  • France

    Poitiers,
    France

    Site Not Available

  • Lithuania

    Vilnius,
    Lithuania

    Site Not Available

  • Poland

    Białystok,
    Poland

    Site Not Available

  • Poland

    Białystok,
    Poland

    Site Not Available

  • Poland

    Inowrocław,
    Poland

    Site Not Available

  • Poland

    Inowrocław,
    Poland

    Site Not Available

  • Poland

    Oleśnica,
    Poland

    Site Not Available

  • Poland

    Oleśnica,
    Poland

    Site Not Available

  • Poland

    Poznań,
    Poland

    Site Not Available

  • Poland

    Poznań,
    Poland

    Site Not Available

  • Poland

    Płock,
    Poland

    Site Not Available

  • Poland

    Płock,
    Poland

    Site Not Available

  • Poland

    Strzelce Opolskie,
    Poland

    Site Not Available

  • Poland

    Warszawa,
    Poland

    Site Not Available

  • Poland

    Łódź,
    Poland

    Site Not Available

  • Poland

    Żyrardów,
    Poland

    Site Not Available

  • Poland

    Łódź,
    Poland

    Site Not Available

  • Poland

    Żyrardów,
    Poland

    Site Not Available

  • Romania

    Brasov,
    Romania

    Site Not Available

  • Romania

    Bucharest,
    Romania

    Site Not Available

  • Romania

    Constanta,
    Romania

    Site Not Available

  • Romania

    Craiova,
    Romania

    Site Not Available

  • Romania

    Iasi,
    Romania

    Site Not Available

  • Romania

    Ploiesti,
    Romania

    Site Not Available

  • Romania

    Sibiu,
    Romania

    Site Not Available

  • Romania

    Targu Mures,
    Romania

    Site Not Available

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