Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00130364 |
This study is not being conducted in the United States of America (USA).
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
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: | Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis |
Estimated Enrollment: | 200 |
Study Start Date: | August 2005 |
Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Pimecrolimus
|
Drug: Pimecrolimus
Pimecrolimus 1 % cream
|
2: Placebo Comparator
Pimecrolimus vehicle cream
|
Drug: Placebo
Pimecrolimus vehicle cream (placebo)
|
Ages Eligible for Study: | 2 Years to 11 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
This study is not being conducted in the United States | |
Novartis Pharmaceuticals, New Jersey, United States |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981C2440 |
Study First Received: | August 12, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00130364 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; South Korea: Korea Food and Drug Administration (KFDA); Slovakia: State Institute for Drug Control |
Atopic dermatitis T-cell pimecrolimus |
children facial Facial atopic dermatitis |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Facies |
Hypersensitivity, Immediate Skin Diseases, Eczematous Pimecrolimus 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 |