Mild to moderate facial atopic dermatitis (AD), in children MedDRA version: M15 Classification code 10003639
Conditions
Interventions
Trade Name: Elidel® 1%
Product Name: Elidel® 1%
Product Code: ASM981C
Pharmaceutical Form: Cream
INN or Proposed INN: pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Concentration un
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 2 to 11 years of age, inclusive - Mild to moderate facial AD at screening (facial IGA 2 – 3; based on assessment of the face only and excluding the ears and the neck). - Patients intolerant of, or dependent on, topical corticosteroids - Diagnosis of AD fulfilling the Hanifin and Rajka criteria - For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At baseline, patients : - with AD on greater than 30% of total body surface area - with concurrent skin disease (e.g. acne) in the study area or active skin infections or other conditions that may interfere with the evaluation - who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or with a history of malignant disease - with previously reported poor, no clinical response or hypersensitivity to topical calcineurin inhibitors such as pimecrolimus cream (Elidel®) and tacrolimus cream (Protopic®) - who received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2 - who received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study - who are unlikely to comply with therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of Elidel® Cream 1% vs. vehicle on the face of mild to moderate AD patients (2 to 11 years, inclusive) who are intolerant of, or dependent on, topical corticosteroidscorticosteroids by testing the hypothesis that a greater percentage of patients treated with Elidel® vs. vehicle will achieve treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear), during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck.;Secondary Objective: To determine the effect of Elidel® vs. vehicle on the overall Eczema Area Severity Index (EASI) score, head and neck EASI score, pruritus score, and time to clearance of facial AD (i.e., a facial IGA score of 0) during the 6-week double-blind phase. In addition, study drug utilization, Eyelid Dermatitis Assessment (EDA) score, safety and tolerability will be assessed at the end of 6 and 12 weeks.;Primary end point(s): Percentage of patients achieving treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear) during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck. | — |
Countries
Germany, Slovakia
Outcome results
None listed