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Tracking Information | |||||
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First Received Date † | December 3, 2007 | ||||
Last Updated Date | September 29, 2008 | ||||
Start Date † | December 2007 | ||||
Current Primary Outcome Measures † |
Investigator's Global Assessment [ Time Frame: End of study compared to baseline ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00568412 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
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 | ||||
Brief Summary | To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Mild to Moderate Atopic Dermatitis | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 80 | ||||
Completion Date | September 2008 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Germany | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00568412 | ||||
Responsible Party | Dr Ulrike Ebert/Medical Advisor, Intendis GmbH | ||||
Secondary IDs †† | |||||
Study Sponsor † | Intendis GmbH | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Intendis GmbH | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |