Dermatopharmacokinetic Trial of LEO 90100 Foam

Overview

This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2018

Interventions

  • Drug: LEO 90100 foam
    • A foam formulation of the active comparator Dovobet® ointment
  • Drug: Dovobet® ointment
    • Ointment formulation containing same active ingredients as LEO 90100 foam

Arms, Groups and Cohorts

  • Experimental: LEO 90100 foam
    • LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g). Pilot part: 6 single applications of LEO 90100 foam on Day 1 (for 12 sites in total). Pivotal part: To be decided based on the result of the pilot part
  • Active Comparator: Dovobet® ointment
    • Pilot part: 6 single applications of Dovobet® ointment on Day 1 (for 12 sites in total). Pivotal part: To be decided based on the result of the pilot part

Clinical Trial Outcome Measures

Primary Measures

  • The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment.
    • Time Frame: 2, 4, 6, 8, 12 and 24 hr after drug application.
    • Amount (nanogram) of calcipotriol and betamethasone dipropionate in the stratum corneum will be compared between the two formulations by selected time points using an ANOVA model with treatment/formulation as systematic effect.

Secondary Measures

  • Safety data – number of adverse events
    • Time Frame: up to 15 Days after drug application
    • Number of adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy Japanese male subjects, aged 20 to 40 years inclusive Exclusion Criteria:

  • Body Mass Index outside the range 18-25 kg/m² – Use of any medication (systemic or topical) within 2 weeks of Day 1.

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, LEO Pharma

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