Atopic Dermatitis
Conditions
Keywords
xerosis, dry skin, dermatitis, eczema, emollient, corticosteroid, flare
Brief summary
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
Interventions
DRUGglycerol, paraffin (liquid and white soft)
1 application in the morning and in the evening
DEVICEAtopiclair®
1 application in the morning, in the afternoon and in the evening
DRUGLocatop@
During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days
DRUGLocapred@
During the 3 months study treatment: 1 application in the evening in case of flare
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age between 2 and 6 years included, * Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is \[15-40\] at inclusion), * After treatment of the current flare, patients should have for randomization an Objective SCORAD score \< 15, with Xerosis intensity≥ 1 and no subjective signs
Exclusion criteria
* Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation, * Primary bacterial, viral, fungal or parasitic skin infection, * Ulcerated lesions, acne or rosacea, * Dermatological disease other than atopic dermatitis which could interfere with the assessment, * Immunosuppression,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with at least one flare over the treatment period | 12 weeks of treatment. | A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (\> 25%) or to the introduction of a new line of therapy(topical corticosteroid). |
Countries
Estonia, France, Lithuania, Poland, Romania
Outcome results
None listed