Dermatitis, Atopic
Conditions
Keywords
Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids
Brief summary
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
Interventions
DRUGPimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
DRUGPimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Severe atopic dermatitis * 5% of total body surface area (TBSA) affected
Exclusion criteria
* Concurrent skin diseases (infections) * Immunocompromised * Recently received phototherapy or systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all other adverse events | — |
| Time to relapse of atopic dermatitis | — |
| Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity) | — |
| Efficacy measured by IGA (treatment success and improvement) | — |
| Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent | — |
Countries
United States
Outcome results
None listed