Psoriasis Vulgaris
Conditions
Brief summary
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.
Interventions
DRUGLEO 90100 foam
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
DRUGVehicle of LEO 90100 foam
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Signed informed consent has been obtained. * Healthy Japanese male subjects. * Aged 20 to 40 years inclusive. Key
Exclusion criteria
* Body Mass Index outside the range 18-25 kg/m² * Use of any medication (systemic or topical) within 2 weeks of Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin irritation | Up to Day 4 | Skin irritation measured as skin irritation index (summation of clinical scores \[ranging from no reaction to blisters\] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments |
| Photo irritation | Up to Day 4 | Positive ratios calculated from the photo irritation scores |
Countries
Japan
Outcome results
None listed