actinic keratoses of the face or scalp MedDRA version: 16.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Ameluz
Product Name: Ameluz
Pharmaceutical Form: Cutaneous emulsion
Trade Name: Metvix
Product Name: Metvix
Pharmaceutical Form: Cutaneous emulsion
Sponsors
Mari Grönroos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Actinic keratoses on both sides of scalp or face Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: pregnancy lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparing the histological and clinical efficacy of two light sensitizers in the daylight-PDT treatment of actinic keratosis;Secondary Objective: Calculating differences in cost-efficacy and assessing pain and primary treatment reaction during and after treatment;Primary end point(s): clinical and histological healing of actinic keratoses;Timepoint(s) of evaluation of this end point: 3 months after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): assessment of treatment reaction;Timepoint(s) of evaluation of this end point: 1 week | — |
Countries
Finland
Contacts
Public ContactNoora Neittaanmäki-Perttu
Noora Neittaanmäki-Perttu
Outcome results
None listed