NCT03673527

Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

• Healthy

Interventions

Type	Name	Description
DRUG	topical formulation of tacrolimus	Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).

Timeline

• Start date: 2018-11-22
• Primary completion: 2019-02-04
• Completion: 2019-02-11
• First posted: 2018-09-17
• Last updated: 2022-04-21

Locations

1 site across 1 country: Germany