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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00367393 |
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.
Condition | Intervention | Phase |
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Atopic Dermatitis |
Drug: Pimecrolimus cream 1% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Multicenter 12-Month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage |
Enrollment: | 41 |
Study Start Date: | March 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pimecrolimus cream 1%
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Drug: Pimecrolimus cream 1%
Pimecrolimus cream 1% bid, as needed
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981CDE20 |
Study First Received: | August 21, 2006 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00367393 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate Skin Diseases, Eczematous |
Pimecrolimus Atrophy Tacrolimus Eczema Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Dermatologic Agents |