Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis
Brief summary
This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
Interventions
DRUGPimecrolimus
Pimecrolimus 1 % cream
DRUGPlacebo
Pimecrolimus vehicle cream (placebo)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Inclusion criteria
* Mild to moderate facial atopic dermatitis * Patients intolerant of, or dependent on, topical corticosteroids
Exclusion criteria
* Concurrent skin diseases (infections) * Immunocompromised * Recently received phototherapy or systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score | — |
| The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score | — |
| The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild) | — |
| Time to clearance of facial IGA (score of 0 or 1) | — |
Countries
United States
Outcome results
None listed