A Vasoconstriction Study With LEO 90100

Study Overview
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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.

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100 Aerosol, foam
* Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle
* Drug: LEO 90100 Aerosol, foam, vehicle
* Drug: Daivobet® ointment
* Drug: Dermovate® cream
* Drug: Synalar® ointment


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 90100<br> | Drug: LEO 90100 Aerosol, foam<br>* 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<br>Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle<br> <br> Drug: LEO 90100 Aerosol, foam, vehicle<br> <br> Drug: Daivobet® ointment<br> <br> Drug: Dermovate® cream<br> <br> Drug: Synalar® ointment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of skin blanching (visual score (VS)) | Visual Assessment of Skin Blanching on scores 0 to 4 | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in colorimetric parameter a* (the red/green balance) at each time point | Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application | 
| Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*) | AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application |