Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis
1 other identifier
interventional
426
1 country
19
Brief Summary
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2002
Shorter than P25 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 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 25, 2008
CompletedSeptember 18, 2014
September 1, 2014
11 months
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:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
New Haven, Connecticut, 06519, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Chicago, Illinois, 60614, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Clinton Township, Michigan, 48308, United States
Unknown Facility
Fridley, Minnesota, 55432, United States
Unknown Facility
Omaha, Nebraska, 68144, United States
Unknown Facility
Reno, Nevada, 89511, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Portland, Oregon, 97201, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15218, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
Houston, Texas, 62016, United States
Related Publications (2)
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.
PMID: 15858471BACKGROUNDKirsner 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: 20107727BACKGROUND
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 25, 2008
Study Start
December 1, 2002
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
September 18, 2014
Record last verified: 2014-09