- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667160
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis
September 17, 2014 updated by: Astellas Pharma Inc
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
426
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
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Connecticut
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New Haven, Connecticut, United States, 06519
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Florida
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33155
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Illinois
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Chicago, Illinois, United States, 60614
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Michigan
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Clinton township, Michigan, United States, 48308
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Minnesota
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Fridley, Minnesota, United States, 55432
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Nebraska
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Omaha, Nebraska, United States, 68144
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Nevada
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Reno, Nevada, United States, 89511
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North Carolina
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Durham, North Carolina, United States, 27705
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Wilmington, North Carolina, United States, 28401
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Winston Salem, North Carolina, United States, 27157
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Ohio
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Cleveland, Ohio, United States, 44106
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Oregon
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Portland, Oregon, United States, 97201
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15218
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Texas
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Dallas, Texas, United States, 75390
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Galveston, Texas, United States, 77555
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Houston, Texas, United States, 62016
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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topical
Other Names:
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Active Comparator: 2
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topical
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Eczema Area and Severity Index (EASI)
Time Frame: 6 Weeks
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6 Weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Investigator's Global Atopic Dermatitis Assessment (IGADA)
Time Frame: 6 Weeks
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6 Weeks
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Patient's evaluation of itch
Time Frame: 6 Weeks
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6 Weeks
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Body surface area affected
Time Frame: 6 Weeks
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6 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22. doi: 10.1016/j.jaad.2004.12.038.
- Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
November 1, 2003
Study Completion (Actual)
November 1, 2003
Study Registration Dates
First Submitted
April 23, 2008
First Submitted That Met QC Criteria
April 23, 2008
First Posted (Estimate)
April 25, 2008
Study Record Updates
Last Update Posted (Estimate)
September 18, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Calcineurin Inhibitors
- Tacrolimus
- Pimecrolimus
Other Study ID Numbers
- 20-02-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on tacrolimus ointment
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Astellas Pharma IncCompletedDermatitis, AtopicFrance, United Kingdom, Spain, Belgium, Portugal, Netherlands, Finland, Czech Republic, Germany, Hungary, Italy
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Astellas Pharma IncCompletedDermatitis, AtopicFrance, Germany, Spain, Belgium, Netherlands, Finland, Austria, United Kingdom, Italy, Czech Republic, Switzerland, Portugal, Denmark
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Astellas Pharma IncCompletedDermatitis, AtopicUnited States
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