NCT00667056

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

April 23, 2008

Last Update Submit

September 17, 2014

Conditions

Dermatitis

Keywords

Chronic Allergic Contact DermatitisProtopic

Outcome Measures

Primary Outcomes (1)

  • Success using the Physician's Global Assessment (PGA)

    8 Weeks

Secondary Outcomes (1)

  • Investigator and subject ACD Sign and Symptoms

    8 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: tacrolimus ointment

2

PLACEBO COMPARATOR
Drug: placebo ointment

Interventions

tacrolimus ointmentDRUG

topical

Also known as: Protopic, FK506 ointment
1
placebo ointmentDRUG

topical

2

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a history of allergy to nickel

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Washington D.C., District of Columbia, 20037, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Shawnee, Kansas, 66216, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

New Orleans, Louisiana, 70121, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55417, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Lynchburg, Virginia, 24501, United States

Location

Related Publications (1)

  • 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.

    PMID: 16781290BACKGROUND

MeSH Terms

Conditions

Dermatitis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • use central contact

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

July 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

US(10)