Atopic dermatitis MedDRA version: 16.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: DEXERYL, cream
Product Name: DEXERYL
Product Code: V0034CR
Pharmaceutical Form: Cream
INN or Proposed INN: Glycerol
CAS Number: 56-81-5
Other descriptive name: GLYCEROL
Concentration unit:
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients, male or female children, presenting with the following criteria may be included (V1): Age between 2 and 6 years included, - Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party, - Who has presented within the previous 6 months at least one duly documented flare treated by corticosteroids, - Who present a current flare, - Whose objective SCORAD score is [15-40] (grade 3) at inclusion, - Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's participation in the study, - Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints, - Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation). After treatment of the current flare, patients should have for randomization (V2): - Objective SCORAD score is 1, - No pruritus, no sleep disorders (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Criteria related to pathologies - 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, - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study. * Criteria related to treatments - Use of oral corticosteroids or immunosuppressants during the last 14 days, - Use of topical corticosteroids during the last 7 days, - Use of systemic or local antibiotics on the lesions during the last 7 days, - Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days, - Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics), - History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.;Secondary Objective: To assess the time to first flare, the number of flares To evaluate the consumption of topical corticosteroid To evaluate DEXERYL effect on the skin dryness and pruritus To evaluate DEXERYL on the subjective perception of the skin To document the clinical, local and systemic, safety of DEXERYL;Primary end point(s): Percentage of patients with at least one flare assessed by the investigator over the 12 weeks of treatment In case of occurrence of flare, the patient should be seen as soon as possible by the investigator to confirm the flare, and if necessary to prescribe appropriate treatments. A flare will be defined as following : measurable increased extent or intensity of lesions in less than 2 weeks under continued treatment (in this case: emollient or no emollient), corresponding to a significant increase (> 25%) in medical score (SCORAD or last PO-SCORAD) or to the introduction of a new line of therapy (topical corticosteroid). and reported in the Adverse Event section of the Case Report Form. Should be considered as 2 separate flares, if topical corticosteroid is interrupted during at least 7 days (absence of inflammatory symptoms); otherwise symptoms will be considered as a single flare;Timepoint(s) of evaluation of this end point: D28, D56, D84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Time to first flare assessed by the investigator over the 12 weeks of treatment •Number of patients in complete remission defind as a period without flare of at least 8 weeks without anti-inflammatory treatment (avoidance of irritants / allergens and emollients not included) •Number of patients needing corticosteroids or immunosuppressants over the 12 weeks of treatment •Consumption of corticosteroid: number of days of application, weight of corticosteroid used •Mean xerosis score (from SCORAD) over the 12 weeks of treatment •Mean HI (hydration index) measured by corneometer, over the 12 weeks of treatment •Mean pruritus score (VAS from SCORAD) over the 12 weeks of treatment •Mean sleep loss score (VAS from SCORAD) over the 12 weeks of treatment •Mean SCORAD and objective SCORAD scores assessed by the investigator at every visit over the 12 weeks of treatment •Mean PO-SCORAD (Patient Oriented SCORAD) score assessed daily by the parents over the 12 weeks of treatment •Mean IGA (Investigator Global Assessment) assessed by the investigator at every visit over the 12 weeks of treatment •Mean POEM score (Patient-Oriented Eczema Measure) assessed weekly by parents over the 12 weeks of treatment •Overall assessment of treatment by the patients, •Assessment of the local tolerability (examination of the skin) and the systemic safety (general clinical examination and reported adverse events) •Overall assessment of treatment use by the parents on a 4 point scale at 12th week (only for patients treated by one of 2 emollients).;Timepoint(s) of evaluation of this end point: D28, D56, D84 | — |
Countries
Estonia, Lithuania
Contacts
Public ContactCarine Fabre
PIERRE FABRE MEDICAMENT
Outcome results
None listed