Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

• Status: Completed
• Trial end date: 2019-02-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LEO Pharma
• Treatments: Tacrolimus

Criteria

Key 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.

Key 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