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Completed

NCT Number: NCT03476746

Dermatopharmacokinetic Trial of LEO 90100 Foam

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

LEO 90100 foam

Drug

A foam formulation of the active comparator Dovobet® ointment

Dovobet® ointment

Drug

Ointment formulation containing same active ingredients as LEO 90100 foam

Primary outcomes

  1. 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 outcomes

  1. Safety data - number of adverse events

    Time frame: up to 15 Days after drug application

    Number of adverse events

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2018
Registry last updated
Feb 24, 2025

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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