Vasoconstriction Trial With LEO 90100 Aerosol Foam

Study Overview
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Brief Summary
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Vasoconstriction study with LEO 90100

Detailed Description
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This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching test

Official Title
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Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100 aerosol foam
* Drug: Dermoval®/Dermovate®
* Drug: Diprosone
* Drug: Elocon
* Drug: Locoid
* Other: LEO 90100 foam vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects demonstrating adequate vasoconstriction to Diprosone® ointment within 15 days prior to dosing (unoccluded application of Diprosone® ointment for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)). Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn). Exclusion Criteria: Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the trial results (skin type V and VI on the Fitzpatrick scale). Female subjects who are breastfeeding.

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 aerosol foam<br>LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |
| Active Comparator: Dermoval®/Dermovate®<br>Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |
| Active Comparator: Diprosone®<br>Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |
| Active Comparator: Elocon®<br>Elocon® mometasone furoate 0.1% cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |
| Active Comparator: Locoid®<br>Locoid® hydrocortisone-17-butyrate 0.1% ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |
| Placebo Comparator: LEO 90100 foam vehicle<br>LEO 90100 foam vehicle Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. | Drug: LEO 90100 aerosol foam<br> <br> Drug: Dermoval®/Dermovate®<br> <br> Drug: Diprosone<br> <br> Drug: Elocon<br> <br> Drug: Locoid<br> <br> Other: LEO 90100 foam vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions |  | 18 hours |