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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 0.1% Tacrolimus Ointment in the Treatment of Chronic Allergic Contact Derma

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 Dermatitis with Tacrolimus Ointment

Detailed Summary:
Sponsor: Astellas Pharma Inc

Current Primary Outcome: Success using the Physician's Global Assessment (PGA) [ Time Frame: 8 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Investigator and subject ACD Sign and Symptoms [ Time Frame: 8 Weeks ]

Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: April 23, 2008
Date Started: July 2004
Date Completion:
Last Updated: September 17, 2014
Last Verified: September 2014