A Vasoconstriction Study With LEO 90100

Phase 1CompletedNCT01946386

LEO Pharma35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

LEO 90100 Aerosol, foamDRUG

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, vehicleDRUG

LEO 90100 Aerosol, foam, vehicleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, France

Outcomes

Primary Outcomes

Visual assessment of skin blanching (visual score (VS))

Visual Assessment of Skin Blanching on scores 0 to 4

Time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application

Secondary Outcomes

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

Time frame: 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

Time frame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application

Data from ClinicalTrials.gov

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