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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00666159 |
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis
Condition | Intervention | Phase |
---|---|---|
Dermatitis, Atopic |
Drug: tacrolimus ointment Drug: pimecrolimus cream |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Moderate to Severe Atopic Dermatitis |
Enrollment: | 226 |
Study Start Date: | December 2002 |
Study Completion Date: | May 2003 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: tacrolimus ointment
topical
|
2: Active Comparator |
Drug: pimecrolimus cream
topical
|
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
New Haven, Connecticut, United States, 06519 | |
United States, Florida | |
Miami, Florida, United States, 33136 | |
Miami, Florida, United States, 33155 | |
United States, Illinois | |
Chicago, Illinois, United States, 60614 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Clinton Township, Michigan, United States, 48038 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68144 | |
United States, Nevada | |
Reno, Nevada, United States, 89511 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
Winston Salem, North Carolina, United States, 27157 | |
Wilmington, North Carolina, United States, 28401 | |
United States, Texas | |
Houston, Texas, United States, 77030 |
Study Director: | Use central contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 20-02-005 |
Study First Received: | April 23, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00666159 |
Health Authority: | United States: Institutional Review Board |
Atopic Dermatitis Protopic Pediatric |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Pimecrolimus Tacrolimus Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Immune System Diseases Immunologic Factors 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 |