atopic dermatitis (atopic eczema)
Conditions
Interventions
Product Name: pimecrolimus
Product Code: ASM981
Pharmaceutical Form: Cream
INN or Proposed INN: pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Concentration unit: % percent
Concentr
Sponsors
Novartis Sverige AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 12 years of age or older • 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. “Medically recognized” contraception may, at the investigator’s discretion, include abstinence. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At baseline and throughout the study, patients: • Who have AD on greater than 30% of total body surface area in addition to facial eczema • Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton’s syndrome) • Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma) • Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel) • Who have 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 have 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: The primary objective of this study is to determine the efficacy of Elidel® Cream 1% on the face of mild to moderate AD patients who are intolerant of, or dependent on, topical corticosteroids by testing the hypothesis that a greater percentage of patients treated with Elidel vs. vehicle will achieve a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at the end of a 6-week period. A facial IGA is an assessment of the face only, and does not include the ears or the neck.;Secondary Objective: The secondary objectives of this study are 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 at the end of 6 weeks. In addition, health-related quality of life, study drug utilization, Eyelid Dermatitis assessment (EDA) score, skin atrophy and telangiectasia, safety and tolerability will be assessed at the end of 6 and 12 weeks.;Primary end point(s): Investigators Global Assessment (IGA) of the face at week 6 (Day 43) | — |
Countries
Italy, Sweden
Outcome results
None listed