You are viewing an expired study

This study is not currently recruiting Study Participants on If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Shawnee, Kansas 66216

  • Dermatitis


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


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 is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

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 Dermatitis

Overall Status:


Study Phase:

Phase 4



Minimum Age:

17 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:use central contact
Study Director
Astellas Pharma US, Inc.

Study Dates

Start Date:July 2004
Completion Date:December 2004
Completion Type:Actual
Primary Completion Date:December 2004
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 17, 2014
First Received Date:April 23, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Success using the Physician's Global Assessment (PGA)
Time Frame:8 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator and subject ACD Sign and Symptoms
Time Frame:8 Weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tacrolimus ointment
Arm Name:1
Other Name:Protopic
Intervention Type:Drug
Name:placebo ointment
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Belsito D, Wilson DC, Warshaw E, Fowler J, Ehrlich A, Anderson B, Strober BE, Willetts J, Rutledge ES. A prospective randomized clinical trial of 0.1% tacrolimus ointment in a model of chronic allergic contact dermatitis. J Am Acad Dermatol. 2006 Jul;55(1):40-6. Epub 2006 May 26.

Data Source:

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.