Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-20 @ 11:47 AM
Study NCT ID:
NCT02605057
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2015-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermatopharmacokinetic Trial of LEO 80185 Gel
Sponsor:
LEO Pharma
Organization:
Study Overview
Official Title:
Dermatopharmacokinetic Trial of LEO 80185 Gel
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: