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

September 17, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Kansas
      • Kansas City, Kansas, United States, 66160
      • Shawnee, Kansas, United States, 66216
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
    • New York
      • New York, New York, United States, 10016
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Virginia
      • Lynchburg, Virginia, United States, 24501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: tacrolimus ointment
topical
Other Names:
  • Protopic
  • FK506 ointment
Placebo Comparator: 2
Drug: placebo ointment
topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success using the Physician's Global Assessment (PGA)
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator and subject ACD Sign and Symptoms
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-04-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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