Psoriasis Vulgaris
Conditions
Brief summary
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.
Interventions
DRUGLEO 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
DRUGBetamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle
DRUGLEO 90100 Aerosol, foam, vehicle
DRUGDermovate® cream
DRUGSynalar® ointment
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual assessment of skin blanching (visual score (VS)) | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application | Visual Assessment of Skin Blanching on scores 0 to 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in colorimetric parameter a* (the red/green balance) at each time point | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application | Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change |
| Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*) | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application | AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change |
Countries
France
Outcome results
None listed