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NCT00667056 Clinical Trial

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

Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00667056
Other study ID # 20-04-001
Secondary ID
Status Completed
Phase Phase 4
First received April 23, 2008
Last updated September 17, 2014
Start date July 2004
Est. completion date December 2004

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 17 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus ointment
topical
• placebo ointment
topical

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & 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. Epub 2006 May 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Success using the Physician's Global Assessment (PGA) 8 Weeks No
Secondary Investigator and subject ACD Sign and Symptoms 8 Weeks No
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