Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00667160
First received: April 23, 2008
Last updated: July 9, 2008
Last verified: July 2008
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Purpose
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatitis, Atopic |
Drug: tacrolimus ointment Drug: pimecrolimus cream |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
- Patient's evaluation of itch [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
- Body surface area affected [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 426 |
| Study Start Date: | December 2002 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tacrolimus ointment
topical
Other Names:
|
| Active Comparator: 2 |
Drug: pimecrolimus cream
topical
Other Name: Elidel
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area
- If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria:
- Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
- Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
- Patient has clinically infected Atopic Dermatitis at baseline
- Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
- Patient has a known hypersensitivity to macrolides or any excipient of either study medication
- Patient has a chronic condition which is either not stable or not well controlled
- Patient is pregnant or breast feeding an infant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667160
Locations
| United States, California | |
| San Diego, California, United States, 92123 | |
| 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, 48308 | |
| United States, Minnesota | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68144 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89511 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27705 | |
| Wilmington, North Carolina, United States, 28401 | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15218 | |
| United States, Texas | |
| Dallas, Texas, United States, 75390 | |
| Galveston, Texas, United States, 77555 | |
| Houston, Texas, United States, 62016 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | use central contact | Astellas Pharma US, Inc. |
More Information
No publications provided
| Responsible Party: | Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc. |
| ClinicalTrials.gov Identifier: | NCT00667160 History of Changes |
| Other Study ID Numbers: | 20-02-006 |
| Study First Received: | April 23, 2008 |
| Last Updated: | July 9, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Astellas Pharma Inc:
|
Mild Atopic Dermatitis Protopic Pediatric |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Tacrolimus Pimecrolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013