Back to resultsStudy of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
Primary Purpose
Dermatitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tacrolimus ointment
placebo ointment
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis focused on measuring Chronic Allergic Contact Dermatitis, Protopic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Success using the Physician's Global Assessment (PGA)
Secondary Outcome Measures
Investigator and subject ACD Sign and Symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00667056
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
Keywords
Chronic Allergic Contact Dermatitis, Protopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus ointment
Other Intervention Name(s)
Protopic, FK506 ointment
Intervention Description
topical
Intervention Type
Drug
Intervention Name(s)
placebo ointment
Intervention Description
topical
Primary Outcome Measure Information:
Title
Success using the Physician's Global Assessment (PGA)
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Investigator and subject ACD Sign and Symptoms
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
use central contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16781290
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. doi: 10.1016/j.jaad.2006.03.025. Epub 2006 May 26.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140580 in the JapicCTI-RNo. field
Learn more about this trial
Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
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