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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00667056
Collaborator
(none)
98
Enrollment
10
Locations
2
Arms
5
Duration (Months)
9.8
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: tacrolimus ointment
  • Drug: placebo ointment
 Phase 4

Study Design

Study Type:
Interventional
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 :
Jul 1, 2004
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: tacrolimus ointment
topical
Other Names:
  • Protopic
  • FK506 ointment

    		•
    Placebo Comparator: 2

    Drug: placebo ointment
    topical

    Outcome Measures

    Primary Outcome Measures

    1. Success using the Physician's Global Assessment (PGA) [8 Weeks]

    Secondary Outcome Measures

    1. Investigator and subject ACD Sign and Symptoms [8 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington District of Columbia United States 20037
    2 Kansas City Kansas United States 66160
    3 Shawnee Kansas United States 66216
    4 Louisville Kentucky United States 40202
    5 New Orleans Louisiana United States 70121
    6 Minneapolis Minnesota United States 55417
    7 New York New York United States 10016
    8 Portland Oregon United States 97239
    9 Hershey Pennsylvania United States 17033
    10 Lynchburg Virginia United States 24501

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00667056
    Other Study ID Numbers:
    • 20-04-001
    First Posted:
    Apr 25, 2008
    Last Update Posted:
    Sep 18, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Astellas Pharma Inc
    Chronic Allergic Contact Dermatitis
    Protopic
    Additional relevant MeSH terms:
    Dermatitis
    Dermatitis, Contact
    Dermatitis, Allergic Contact
    Tacrolimus

    Study Results

    No Results Posted as of Sep 18, 2014