Psoriasis Vulgaris
Conditions
Brief summary
The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.
Interventions
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out. * 2\. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.
Exclusion criteria
* 1\. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding * 2\. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other 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 |
|---|---|
| Mean Cumulative Irritation index and maximal dermal response during induction phase | 3 weeks |
| Number of subjects with positive sensitisation reaction at each test site in the challenge phase | 6 weeks |
Countries
France
Outcome results
None listed