A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis
1 other identifier
interventional
413
2 countries
15
Brief Summary
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2002
Shorter than P25 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedSeptember 18, 2014
September 1, 2014
1.1 years
April 23, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Eczema Area and Severity Index (EASI)
6 Weeks
Secondary Outcomes (3)
Investigator's Global Atopic Dermatitis Assessment (IGADA)
6 Weeks
Patient's evaluation of itch
6 Weeks
Body surface area affected
6 Weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
- Negative pregnancy test and agrees to practice effective birth control during the study
You may not qualify if:
- Skin disorder other than Atopic Dermatitis in the areas to be treated
- Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
- Clinically infected Atopic Dermatitis at baseline
- Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
- Known hypersensitivity to macrolides or any excipient of either study medication
- Chronic condition which is either not stable or not well controlled
- Pregnant or breast feeding an infant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
San Francisco, California, 94118, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Halifax, Nova Scotia, B3H 1V7, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 1Z4, Canada
Related Publications (3)
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.
PMID: 20107727BACKGROUNDPaller 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.
PMID: 15858471BACKGROUNDFleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332.
PMID: 17538803BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use central contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
October 1, 2002
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
September 18, 2014
Record last verified: 2014-09