Actinic keratoses MedDRA version: 18.1 Level: LLT Classification code 10041304 Term: Solar keratosis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Metvix
Pharmaceutical Form: Cream
INN or Proposed INN: methyl aminolevulinate
CAS Number: 33320-16-0
Other descriptive name: METHYL AMINOLEVULINATE
Concentration unit: mg/g milligram(s)/gr
Sponsors
Department of Dermatology, Bispebjerg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Actinic keratoses in the face and scalp Age above 18 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Immunosuppressive treatment MAO-inhibitor, TCA or mirtazapin/miansering/maprotilin treatment Pregnancy Porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce treatment induced erythema during photodynamic therapy;Secondary Objective: Pain during photodynamic therpy Efficacy of puls-photodynamic therapy in the treatment of actinic keratoses ;Primary end point(s): Reduction in erythema ;Timepoint(s) of evaluation of this end point: 1-2 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete lesion response rate Maximal pain score;Timepoint(s) of evaluation of this end point: 3 months after treatment During treatment | — |
Countries
Denmark
Contacts
Public ContactStine Regin Wiegell
Department of Dermatology, Bispebjerg University Hospital
Outcome results
None listed