A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Phase 4
Completed
- Conditions
- Mild to Moderate Atopic Dermatitis
- Interventions
- Device: Zarzenda
- Registration Number
- NCT00568412
- Lead Sponsor
- Bayer
- Brief Summary
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- male and female children and adolescents (aged 2 - 17)
- mild to moderate atopic dermatitis
- patients in whom a treatment with topical corticosteroids in not recommended or possible
- wash out periods to be observed
Exclusion Criteria
- known allergy to one of the two treatments
- known immunodeficiency
- known hepatic or renal insufficiency
- acute skin infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Zarzenda Zarzenda applied topically twice daily for three weeks 2 Elidel Elidel 1% cream, applied topically twice daily for three weeks
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment End of study compared to baseline
- Secondary Outcome Measures
Name Time Method Affected body surface area End of study compared to baseline Children's Dermatological Life Quality Index End of study compared to baseline EASI End of study compared to baseline Patient's assessment of itch, quality of sleep, and global assessment End of study compared to baseline
Trial Locations
- Locations (1)
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
🇩🇪Bonn, Germany