Photodynamic therapy without curettage

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001701-33-DK

Enrollment

Registered

2017-04-24

Start date

2017-05-19

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream INN or Proposed INN: Methyl aminovulinate Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Actinic keratosis in the face or scalp 18 years or older Informed written and oral consent 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: Allergy to constituent of the used medication (Metvix) Pregnancy or breastfeeding Patient with known hypersensitivity to sunlight Patients not belived to be able to follow the protocol Local treatment of the examined skin in the past month

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate if photodynamic therapy without curettage is equally effective as photodynamic therapy with curettage. ;Secondary Objective: Investigate adverse effects: pain, erythema, cosmetic outcome, downgrading of AKs, PpIX concentraion in the skin ;Primary end point(s): Clearance rate 3 months after treatment. It is assessed wheter each lesion is complete disappeared after treatment or not. ;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: Investigate if photodynamic therapy without curettage is equally effective as photodynamic therapy with curettage. ;Secondary Objective: Investigate adverse effects: pain, erythema, cosmetic outcome, downgrading of AKs, PpIX concentraion in the skin ;Primary end point(s): Clearance rate 3 months after treatment. It is assessed wheter each lesion is complete disappeared after treatment or not. ;Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): Investigate adverse effects: pain, erythema, cosmetic outcome, downgrading of AKs, PpIX concentration in the skin ;Timepoint(s) of evaluation of this end point: Pain: during treatment. Erythema: 1-2 days after treatment. Cosmetic outcome: 3 months after treatment. Downgrading of AKs: 3 months after treatment. PpIX concentration: during treatment.	—

Countries

Denmark

Contacts

Public ContactDepartment of Dermatolgy, D92

Bispebjerg Hospital

hans.christian.wulf@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026