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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03669757` - Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis	Phase 1
Completed	`NCT03614078` - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis	Phase 2
Completed	`NCT03584360` - Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin	Phase 2
Recruiting	`NCT04994951` - Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome.	Phase 2
Completed	`NCT02888236` - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris	Phase 2
Completed	`NCT02533973` - Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population	Phase 4
Completed	`NCT02193815` - A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis	Phase 1
Completed	`NCT01946386` - A Vasoconstriction Study With LEO 90100	Phase 1
Completed	`NCT02004847` - Blue Light for Treating Psoriasis Vulgaris	N/A
Recruiting	`NCT01443338` - Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2	Phase 4
Completed	`NCT01188928` - LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)	Phase 3
Completed	`NCT00764751` - Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris	Phase 2
Completed	`NCT00236171` - Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test	N/A
Completed	`NCT04541329` - Predicting Inflammatory Skin Disease Response to IL-23 Blockade	Phase 4
Completed	`NCT06064084` - Incretin Effect in Patients With Psoriasis and Controls
Not yet recruiting	`NCT06398106` - Proactive TDM Versus Standard Use of Biologics in Psoriasis	Phase 4
Recruiting	`NCT05390515` - Psoriatic Immune Response to Tildrakizumab	Phase 4
Recruiting	`NCT05892640` - Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis	N/A
Recruiting	`NCT04950218` - The Psoriasis Echo Study
Completed	`NCT05184348` - Plexin B2 Gene Expression and Polymorphisms in Psoriasis	Phase 1