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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00667056

Enrollment

Registered

2008-04-25

Start date

2004-07-31

Completion date

2004-12-31

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis

Keywords

Chronic Allergic Contact Dermatitis, Protopic

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

Interventions

DRUGtacrolimus ointment

topical

DRUGplacebo ointment

topical

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Success using the Physician's Global Assessment (PGA)	8 Weeks

Secondary

Measure	Time frame
Investigator and subject ACD Sign and Symptoms	8 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026