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Sponsored by: |
Intendis GmbH |
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Information provided by: | Intendis GmbH |
ClinicalTrials.gov Identifier: | NCT00568412 |
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
Condition | Intervention | Phase |
---|---|---|
Mild to Moderate Atopic Dermatitis |
Device: Zarzenda Drug: Elidel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 80 |
Study Start Date: | December 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Zarzenda applied topically twice daily for three weeks
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Device: Zarzenda
Topical cream, applied twice daily for three weeks
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2: Active Comparator
Elidel 1% cream, applied topically twice daily for three weeks
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Drug: Elidel
1% cream, applied topically twice daily for three weeks
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Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum | |
Bonn, Germany, 53105 |
Principal Investigator: | Thomas Bieber, Prof | Klinik und Poliklinik fuer Dermatologie, Universitaetsklinikum Bonn, Germany |
Responsible Party: | Intendis GmbH ( Dr Ulrike Ebert/Medical Advisor ) |
Study ID Numbers: | 1401920 |
Study First Received: | December 3, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00568412 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
atopic dermatitis |
Anti-Inflammatory Agents Dermatitis, Atopic Immunologic Factors Skin Diseases Pimecrolimus Immunosuppressive Agents Hypersensitivity Genetic Diseases, Inborn Analgesics, Non-Narcotic |
Hypersensitivity, Immediate Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Dermatitis, Atopic Immunologic Factors Skin Diseases Immune System Diseases Physiological Effects of Drugs Pimecrolimus Immunosuppressive Agents Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Dermatologic Agents Skin Diseases, Genetic Dermatitis |