Psoriasis Vulgaris
Conditions
Brief summary
Vasoconstriction study with LEO 90100
Detailed description
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
Interventions
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
* 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.
Design outcomes
Primary
| Measure | 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 |
Countries
France
Outcome results
None listed