Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis

Completed · Phase 4 · Has a placebo group

Conditions studied: Dermatitis

In brief

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 Dermatitis with Tacrolimus Ointment

Key facts

Study ID

NCT00667056

Run by

Astellas Pharma Inc

People needed

98

Starts

2004-07-01

Expected to finish

2004-12-01

Last updated by the study team

2014-09-18

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a history of allergy to nickel

You may not qualify if…

• 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

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Kansas City, Kansas, United States
• Study site — Shawnee, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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