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

Phase 4

Completed

• Conditions: Dermatitis
• Interventions: Drug: tacrolimus ointment; Drug: placebo ointment

• Registration Number: NCT00667056
• Lead Sponsor: Astellas Pharma Inc

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 Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Subject has a history of allergy to nickel

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tacrolimus ointment	-
2	placebo ointment	-

Primary Outcome Measures

Name	Time	Method
Success using the Physician's Global Assessment (PGA)	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Investigator and subject ACD Sign and Symptoms	8 Weeks