Actinic keratoses MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Metvix
Product Name: Metvix
Product Code: 32850
Pharmaceutical Form: Cream
CAS Number: 79416-27-6
Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE
Trade Name: Dermovat
Product
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Above 18 years old Actinic keratosis in the face and scalp 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 15
Exclusion criteria
Exclusion criteria: Immunosuppression Pregnancy Porphyria Allergy to Metvix or Dermovat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: methods for reducing inflammation after photodynamic therapy;Secondary Objective: Efficacy, pain and PpIX fluorescence;Primary end point(s): redness after treatment;Timepoint(s) of evaluation of this end point: 1-2 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): efficacy, pain and PpIX fluorescence;Timepoint(s) of evaluation of this end point: 3 month after treatment and during treatment | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology
Bispebjerg Hospital
Outcome results
None listed