Dermatopharmacokinetic Trial of LEO 90100 Foam

NCT ID: NCT03476746

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

A single application of LEO 90100 foam and Dovobet® ointment will be applied to multiple test sites on the innerside of both arms of trial subjects. The trial consists of 2 parts. The first part, (pilot part) will evaluate the pharmacokinetic profile of LEO 90100 foam and Dovobet® ointment by measuring the amount of each of the active ingredients in the stratum corneum and determine conditions for the second part of the trial. The second part (pivotal part) will compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 90100 foam and Dovobet® ointment. The sample size and the number of application sites in the pivotal part will be determined based on the results of the pilot part.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

LEO 90100 foam

Intervention Type DRUG

A foam formulation of the active comparator Dovobet® ointment

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

Group Type ACTIVE_COMPARATOR

Dovobet® ointment

Intervention Type DRUG

Ointment formulation containing same active ingredients as LEO 90100 foam

Interventions

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LEO 90100 foam

A foam formulation of the active comparator Dovobet® ointment

Intervention Type DRUG

Dovobet® ointment

Ointment formulation containing same active ingredients as LEO 90100 foam

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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Investigational site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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LP0053-1417

Identifier Type: -

Identifier Source: org_study_id

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