Dermatopharmacokinetic Trial of LEO 90100 Foam

NCT03476746 | Completed Phase 1

• 1 other identifier: LP0053-1417
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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.

  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.

  2, 4, 6, 8, 12 and 24 hr after drug application.

Secondary Outcomes (1)

• Safety data - number of adverse events

  up to 15 Days after drug application

Study Arms (2)

LEO 90100 foam

EXPERIMENTAL

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

Drug: LEO 90100 foam

Dovobet® ointment

ACTIVE COMPARATOR

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

Drug: Dovobet® ointment

Interventions

LEO 90100 foam DRUG

A foam formulation of the active comparator Dovobet® ointment

LEO 90100 foam

Dovobet® ointment DRUG

Ointment formulation containing same active ingredients as LEO 90100 foam

Dovobet® ointment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Investigational site

Fukuoka, 812-0025, Japan

Location

Study Officials

• Study Director

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 26, 2018
• Study Start: March 20, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 24, 2025

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)