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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 23, 2008
Last updated: September 17, 2014
Last verified: September 2014
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

Condition Intervention Phase
Drug: tacrolimus ointment
Drug: placebo ointment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Success using the Physician's Global Assessment (PGA) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator and subject ACD Sign and Symptoms [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: July 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus ointment
Other Names:
  • Protopic
  • FK506 ointment
Placebo Comparator: 2 Drug: placebo ointment


Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00667056

United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Kansas
Kansas City, Kansas, United States, 66160
Shawnee, Kansas, United States, 66216
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Minneapolis, Minnesota, United States, 55417
United States, New York
New York, New York, United States, 10016
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Virginia
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: use central contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00667056     History of Changes
Other Study ID Numbers: 20-04-001 
Study First Received: April 23, 2008
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Chronic Allergic Contact Dermatitis

Additional relevant MeSH terms:
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 08, 2016