Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2019-02-11

Brief Summary

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This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.

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Detailed Description

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The purpose of this trial is to assess the safety of a topical formulation of tacrolimus.

Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects will be enrolled in the trial and will be assigned to receive topical application of tacrolimus twice daily for 14 days.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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topical formulation of tacrolimus

Group Type EXPERIMENTAL

topical formulation of tacrolimus

Intervention Type DRUG

Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).

Interventions

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topical formulation of tacrolimus

Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between 18 and 60 years of age, with a body mass index (BMI) between 18.5 and 30 kg/m2 inclusive
* Female subjects of childbearing potential must be confirmed not pregnant at the screening visit and use highly effective contraception during the trial.

Exclusion Criteria

* Treatment with the following medications: Topical immunosuppressive drugs (e.g. tacrolimus, corticosteroids), systemic immunosuppressive/immunomodulating drugs
* Extensive UV radiation or sunlight on the application sites
* Skin diseases
* Wounded or damaged skin at the application site
* Immunosuppressed or immunocompromised individuals
* Renal or hepatic impairment or insufficiency
* Known allergy or known or suspected hypersensitivity to any component(s) of the topical formulation of tacrolimus
* Female subjects who are pregnant or lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes