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Shawnee, Kansas 66216

  • Dermatitis

Purpose:

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


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


Study is Available At:


Original ID:

20-04-001


NCT ID:

NCT00667056


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

17 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

98


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:July 2004
Completion Date:December 2004
Completion Type:Actual
Primary Completion Date:December 2004
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 17, 2014
First Received Date:April 23, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Success using the Physician's Global Assessment (PGA)
Time Frame:8 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator and subject ACD Sign and Symptoms
Time Frame:8 Weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tacrolimus ointment
Description:topical
Arm Name:1
Other Name:Protopic
Intervention Type:Drug
Name:placebo ointment
Description:topical
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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. Epub 2006 May 26.
PMID:16781290

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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