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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667056
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dermatitis Drug: tacrolimus ointment Drug: placebo ointment Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
Other Names:
  • Protopic
  • FK506 ointment
Placebo Comparator: 2 Drug: placebo ointment

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

Secondary Outcome Measures :
  1. Investigator and subject ACD Sign and Symptoms [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00667056     History of Changes
Other Study ID Numbers: 20-04-001
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
Chronic Allergic Contact Dermatitis

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action