Trial Condition(s):
Mild to Moderate Atopic Dermatitis
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Bayer Identifier:
1401920
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Investigator's Global AssessmentTimeframe: End of study compared to baseline
Secondary Outcome
- EASITimeframe: End of study compared to baseline
- Affected body surface areaTimeframe: End of study compared to baseline
- Patient's assessment of itch, quality of sleep, and global assessmentTimeframe: End of study compared to baseline
- Children's Dermatological Life Quality IndexTimeframe: End of study compared to baseline
Additional Information
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