A Vasoconstriction Study With LEO 90100

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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LEO 90100

Group Type EXPERIMENTAL

LEO 90100 Aerosol, foam

Intervention Type DRUG

The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours

Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle

Intervention Type DRUG

LEO 90100 Aerosol, foam, vehicle

Intervention Type DRUG

Daivobet® ointment

Intervention Type DRUG

Dermovate® cream

Intervention Type DRUG

Synalar® ointment

Intervention Type DRUG

Interventions

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LEO 90100 Aerosol, foam

The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours

Intervention Type DRUG

Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle

Intervention Type DRUG

LEO 90100 Aerosol, foam, vehicle

Intervention Type DRUG

Daivobet® ointment

Intervention Type DRUG

Dermovate® cream

Intervention Type DRUG

Synalar® ointment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
* Healthy male or female volunteers, 18 to 50 years old, both inclusive

Exclusion Criteria

* Female subjects who are pregnant or who are breast feeding.
* Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes