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Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Primary Purpose

Skin and Connective Tissue Diseases

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

LEO 80185 gel, vehicle, liquid paraffin

About this trial

This is an interventional treatment trial for Skin and Connective Tissue Diseases focused on measuring LEO 80185 gel, calcipotriol, betamethasone

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Signed informed consent has been obtained.
Healthy Japanese male subjects.
Aged 20 to 40 years inclusive.
Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
Subjects without a significant abnormality, as judged by the (sub)investigator

Exclusion Criteria:

Body Mass Index outside the range 18-25 kg/m²
History of alcohol or drug abuse.
History of allergic reaction to any medications.
Any disease that could in any way confound assessment of the test sites.
Known or suspected hypersensitivity to any component of LEO 80185 gel.
Known or suspected hepatic, renal or cardiac disorders.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis).
Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
Use of any medication (systemic or topical) within 2 weeks of Day 1.
Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest.
Current participation in any other interventional clinical trial.
Previously enrolled in this clinical trial.
Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
In the opinion of the (sub)investigator, participation in the trial is inappropriate.

Sites / Locations

Medical Co. LTA HAKATA Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LEO 80185 gel, vehicle, liquid paraffin

Arm Description

Each subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner.

Outcomes

Primary Outcome Measures

Skin irritation measured as -, +/-, +, ++, +++, ++++

Secondary Outcome Measures

Full Information

NCT ID

NCT02379793

First Posted

February 26, 2015

Last Updated

June 13, 2016

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02379793

Brief Title

Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Official Title

Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin and Connective Tissue Diseases

Keywords

LEO 80185 gel, calcipotriol, betamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LEO 80185 gel, vehicle, liquid paraffin

Arm Type

Experimental

Arm Description

Each subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner.

Intervention Type

Drug

Intervention Name(s)

LEO 80185 gel, vehicle, liquid paraffin

Intervention Description

Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.

Primary Outcome Measure Information:

Title

Skin irritation measured as -, +/-, +, ++, +++, ++++

Time Frame

4 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent has been obtained. Healthy Japanese male subjects. Aged 20 to 40 years inclusive. Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn). Subjects without a significant abnormality, as judged by the (sub)investigator Exclusion Criteria: Body Mass Index outside the range 18-25 kg/m² History of alcohol or drug abuse. History of allergic reaction to any medications. Any disease that could in any way confound assessment of the test sites. Known or suspected hypersensitivity to any component of LEO 80185 gel. Known or suspected hepatic, renal or cardiac disorders. Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening. Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis). Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1. Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1. Use of any medication (systemic or topical) within 2 weeks of Day 1. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest. Current participation in any other interventional clinical trial. Previously enrolled in this clinical trial. Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight). Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1. Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4). In the opinion of the (sub)investigator, participation in the trial is inappropriate.

Facility Information:

Facility Name

Medical Co. LTA HAKATA Clinic

City

Random Square 5F, 6-18 Tenyamachi, Hakata-ku

State/Province

Fukuoka

ZIP/Postal Code

812-0025

Country

Japan

12. IPD Sharing Statement

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Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

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