Healthy volunteers - no medical condition is investigated but pharmaco kinetics MedDRA version: 17.0 Level: HLGT Classification code 10040879 Term: Skin investigations System Organ Class: 10022891 - Investigations
Conditions
Sponsors
Department of Dermatology D92, Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers 18 years or older informed and written consent Fertile women have to use safe contraceptive measures Medical record with regards to medical treatment is mandatory before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Allergy to the creams and ointments used in the trial Relevant active skin disease in treatment area Pregnancy or breastfeeding Concurrent participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measure formation of PpIX in healthy volunteers over a period of 24 hours. In addition establish if pre treatment with curettage or two ointments used to treat psoriasis have an effect on PpIX formation;Secondary Objective: Not applicable;Primary end point(s): Amount of PpIX formed over a period of 24 hours;Timepoint(s) of evaluation of this end point: Hourly for 5 hours and after 18, 21, 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology D92,
Bispebjerg Hospital
Outcome results
None listed