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Completed

NCT Number: NCT03673527

Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

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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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Neu-Ulm, Bavaria, 89231, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical formulation of tacrolimus

Drug

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

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14

    Time frame: Up to Day 14

  2. Maximum Observed Drug Concentration (Cmax) of tacrolimus

    Time frame: On Days 1 and 14

Secondary outcomes

  1. Number of adverse events (AEs) up to Day 21

    Time frame: Day -22 to Day 21

  2. Number of subjects with AEs up to Day 21

    Time frame: Day -22 to Day 21

  3. Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: mmHg

  4. Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: bpm

  5. Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: °C

  6. Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: mmHg

  7. Changes in pulse from baseline to Day 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: bpm

  8. Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation

    Time frame: Day 1 to Day 21

    Measurement unit: °C

  9. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14

    Time frame: Day 1 to Day 14

  10. Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14

    Time frame: Day 1 to Day 14

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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