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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00117377 |
The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: Pimecrolimus Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis |
Estimated Enrollment: | 70 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Pimecrolimus
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Drug: Pimecrolimus
Pimecrolimus cream 1 % bid
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2: Placebo Comparator
Placebo control twice daily application
|
Drug: Placebo
Placebo application bid
|
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion criteria for patients with atopic dermatitis:
Inclusion criteria for healthy volunteers:
Exclusion Criteria:
Exclusion criteria for patients with atopic dermatitis:
Exclusion criteria for healthy volunteers:
United States, New York | |
New York University Hospital | |
New York, New York, United States | |
Mount Sinai School of Medicine | |
New York, New York, United States | |
United States, Virginia | |
Virginia Clinical Research, Inc | |
Norfolk, Virginia, United States |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981C2436 |
Study First Received: | June 30, 2005 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00117377 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Atopic dermatitis, pimecrolimus, cellular, molecular |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Pimecrolimus Tacrolimus 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 |