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Completed

NCT Number: NCT01467362

Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

desonide 0.1% cream

Drug

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

Other names: Locapred

Foaming gel

Other

for the washing and cleaning

Other names: Pediatril

Primary outcomes

  1. 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)

Secondary outcomes

  1. Hydration Index score : measurement of the skin hydration

    Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84

  2. 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

  3. Xerosis Visual Analogue Scale (evaluation skin dryness)

    Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84

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

    Time frame: Day1, Day 28, Day 56 and Day 84.

  5. Overall assessment of treatment efficacy by the investigator

    Time frame: Day 28 and Day 84

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

    Time frame: at Day 28 and at Day 84

  7. 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

  8. Topical corticosteroid assessment

    Time frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2011
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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