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

Astellas

Status and phase: Completed; Phase 4

Conditions: Dermatitis

Treatments: Drug: placebo ointment; Drug: tacrolimus ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667056

20-04-001

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 17+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tacrolimus ointment

2

Placebo Comparator group

Treatment:

Drug: placebo ointment