Dermatopharmacokinetic Trial of LEO 80185 Gel

Status Completed

Clinical Trial Summary

Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.

Clinical Trial Description

The study consists of two phases:

The pilot: The first part, known as the pilot study, will include 8 subjects and will evaluate pharmacokinetic profile of LEO 80185 gel and Dovobet® Ointment by measuring the amount of each of the active ingredients in the stratum corneum.

Pivotal: The second part, known as the pivotal study, is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The number of subjects in the pivotal study and the number of application sites for study medications will be based on the results of the pilot study.

The number of subjects included in the trial and design of trial is in line with previous type of DPK trials in Japan and the Japanese guideline ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02605057
Study type	Interventional
Source	LEO Pharma
Contact
Status	Completed
Phase	Phase 1
Start date	November 2015
Completion date	July 2016

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