Atopic Dermatitis
Conditions
Keywords
xerosis, dry skin, dermatitis, pruritus, eczema, emollient, corticosteroid
Brief 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.
Interventions
DRUGV0034CR01B
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
DRUGVehicle cream
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
DRUGdesonide 0.1% cream
cream, once a day (in the evening) during flares
OTHERFoaming gel
for the washing and cleaning
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Xerosis score: mean evolution over the different time-points of double-blind period | During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28) |
Secondary
| Measure | Time frame |
|---|---|
| Xerosis score evolution over the different time-ponts during open label period | At Visit1 (Day 1) and at Day 56 and Day 84 |
| Xerosis Visual Analogue Scale (evaluation skin dryness) | Day 1, Day 14, Day 28, Day 56 and Day 84 |
| Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis. | Day1, Day 28, Day 56 and Day 84. |
| Hydration Index score : measurement of the skin hydration | Day 1, Day 14, Day 28, Day 56 and Day 84 |
| Overall assessment of treatment efficacy and use by the parent(s)/guardian(s) | at Day 28 and at Day 84 |
| Assessment of the local tolerability and the systemic safety (reported adverse events) | Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 |
| Topical corticosteroid assessment | Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 |
| Overall assessment of treatment efficacy by the investigator | Day 28 and Day 84 |
Countries
Estonia, France, Lithuania, Poland, Romania
Outcome results
None listed