Status:
COMPLETED
Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis
Eligibility:
All Genders
17+ years
Phase:
PHASE4
Brief Summary
A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatiti...
Eligibility Criteria
Inclusion
- Subject has a history of allergy to nickel
Exclusion
- Subject is pregnant or lactating
- Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity
- Subject has a known hypersensitivity to any component of the test medications
- Subject has any other significant dermatological condition that affects \>10% of the body surface area or general medical condition that could interfere with the study evaluation
- Subject has any significant medical condition that could compromise immune responsiveness
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00667056
Start Date
July 1 2004
End Date
December 1 2004
Last Update
September 18 2014
Active Locations (10)
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1
Washington D.C., District of Columbia, United States, 20037
2
Kansas City, Kansas, United States, 66160
3
Shawnee, Kansas, United States, 66216
4
Louisville, Kentucky, United States, 40202