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

NCT ID: NCT00667056

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

tacrolimus ointment

Intervention Type DRUG

topical

2

Group Type PLACEBO_COMPARATOR

placebo ointment

Intervention Type DRUG

topical

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tacrolimus ointment

topical

Intervention Type DRUG

placebo ointment

topical

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Protopic FK506 ointment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

use central contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington D.C., District of Columbia, United States

Site Status

Kansas City, Kansas, United States

Site Status

Shawnee, Kansas, United States

Site Status

Louisville, Kentucky, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

New York, New York, United States

Site Status

Portland, Oregon, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Lynchburg, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16781290 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-04-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.