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OpenTrials
Completed

NCT Number: NCT00667056

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

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

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Key information

Conditions

Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus ointment

Drug

topical

Other names: Protopic, FK506 ointment

Placebo Ointment

Drug

topical

Primary outcomes

  1. Success using the Physician's Global Assessment (PGA)

    Time frame: 8 Weeks

Secondary outcomes

  1. Investigator and subject ACD Sign and Symptoms

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 25, 2008
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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