A Phase 3 interventional study of V0034CR01B and Vehicle cream in Atopic Dermatitis, sponsored by Pierre Fabre Medicament. Completed at 25 sites in 5 countries. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2013-02-21.
Sponsored by Pierre Fabre Medicament · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 251 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: V0034CR01B · Drug: desonide 0.1% cream · Other: Foaming gel
Drug: Vehicle cream · Drug: desonide 0.1% cream · Other: Foaming gel
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
cream, once a day (in the evening) during flares
Also known as: Locapred
for the washing and cleaning
Also known as: Pediatril
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)
Hydration Index score : measurement of the skin hydration
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
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
Xerosis Visual Analogue Scale (evaluation skin dryness)
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
Time frame: Day1, Day 28, Day 56 and Day 84.
Overall assessment of treatment efficacy by the investigator
Time frame: Day 28 and Day 84
Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
Time frame: at Day 28 and at Day 84
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
Topical corticosteroid assessment
Time frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Medicament