Back to resultsA Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Primary Purpose
Mild to Moderate Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Zarzenda
Elidel
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Atopic Dermatitis focused on measuring atopic dermatitis
Eligibility Criteria
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
Sites / Locations
- Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Zarzenda applied topically twice daily for three weeks
Elidel 1% cream, applied topically twice daily for three weeks
Outcomes
Primary Outcome Measures
Investigator's Global Assessment
Secondary Outcome Measures
EASI
Affected body surface area
Patient's assessment of itch, quality of sleep, and global assessment
Children's Dermatological Life Quality Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568412
Brief Title
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Atopic Dermatitis
Keywords
atopic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Zarzenda applied topically twice daily for three weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Elidel 1% cream, applied topically twice daily for three weeks
Intervention Type
Device
Intervention Name(s)
Zarzenda
Intervention Description
Topical cream, applied twice daily for three weeks
Intervention Type
Drug
Intervention Name(s)
Elidel
Intervention Description
1% cream, applied topically twice daily for three weeks
Primary Outcome Measure Information:
Title
Investigator's Global Assessment
Time Frame
End of study compared to baseline
Secondary Outcome Measure Information:
Title
EASI
Time Frame
End of study compared to baseline
Title
Affected body surface area
Time Frame
End of study compared to baseline
Title
Patient's assessment of itch, quality of sleep, and global assessment
Time Frame
End of study compared to baseline
Title
Children's Dermatological Life Quality Index
Time Frame
End of study compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
City
Bonn
ZIP/Postal Code
53105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
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