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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: topical formulation of tacrolimus

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Neu-Ulm, Bavaria, Germany, 89231
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical formulation of tacrolimus	Drug: topical formulation of tacrolimus; Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14	Up to Day 14
Maximum Observed Drug Concentration (Cmax) of tacrolimus	On Days 1 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events (AEs) up to Day 21		Day -22 to Day 21
Number of subjects with AEs up to Day 21		Day -22 to Day 21
Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation	Measurement unit: mmHg	Day 1 to Day 21
Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation	Measurement unit: bpm	Day 1 to Day 21
Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation	Measurement unit: °C	Day 1 to Day 21
Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation	Measurement unit: mmHg	Day 1 to Day 21
Changes in pulse from baseline to Day 21 summarised by mean and standard deviation	Measurement unit: bpm	Day 1 to Day 21
Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation	Measurement unit: °C	Day 1 to Day 21
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14		Day 1 to Day 14
Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14		Day 1 to Day 14

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2018
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: open-label; multiple-dose; non-randomised; non-comparative
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: LP0121-1388; 2018-001959-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No