Sun damage skin MedDRA version: 14.1 Level: LLT Classification code 10063071 Term: Solar elastosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Metvix
Product Name: Metvix
Product Code: 32850
Pharmaceutical Form: Cream
Sponsors
Bispeberg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: sun damage skin above age of 18 years 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: immunosuppresion pregnancy porphyria allergy to metvix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reducing light sensitivity after photodynamic therapy using sun protection factors;Secondary Objective: PpIX fluorescence and pain during therapy;Primary end point(s): skin redness after treatment;Timepoint(s) of evaluation of this end point: 1-2 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ppx fluorescence pain;Timepoint(s) of evaluation of this end point: during and 1-2 days after treatment | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology
Bispebjerg Hospital
Outcome results
None listed