Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01467362
First received: October 24, 2011
Last updated: February 20, 2013
Last verified: February 2013

October 24, 2011
February 20, 2013
November 2011
May 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467362 on ClinicalTrials.gov Archive Site
  • Hydration Index score : measurement of the skin hydration [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Xerosis Visual Analogue Scale (evaluation skin dryness) [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
  • Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis. [ Time Frame: Day1, Day 28, Day 56 and Day 84. ] [ Designated as safety issue: No ]
  • Overall assessment of treatment efficacy by the investigator [ Time Frame: Day 28 and Day 84 ] [ Designated as safety issue: No ]
  • Overall assessment of treatment efficacy and use by the parent(s)/guardian(s) [ Time Frame: at Day 28 and at Day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Topical corticosteroid assessment [ Time Frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Emollient on Xerosis in Children With Atopic Dermatitis
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: V0034CR01B
    Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
  • Drug: Vehicle cream
    Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
  • Drug: desonide 0.1% cream
    cream, once a day (in the evening) during flares
    Other Name: Locapred
  • Other: Foaming gel
    for the washing and cleaning
    Other Name: Pediatril
  • Experimental: V0034CR01B
    Interventions:
    • Drug: V0034CR01B
    • Drug: desonide 0.1% cream
    • Other: Foaming gel
  • Placebo Comparator: Vehicle cream
    Interventions:
    • Drug: Vehicle cream
    • Drug: desonide 0.1% cream
    • Other: Foaming gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   France,   Lithuania,   Poland,   Romania
 
NCT01467362
V00034 CR 3 12 1B, 2011-003295-37
No
Pierre Fabre Medicament
Pierre Fabre Medicament
Not Provided
Principal Investigator: Franck BORALEVI, Pr Health centre
Pierre Fabre Medicament
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP