PpIX in curetted and non-curetted skin after Metvix application

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005084-14-DK

Enrollment

Unknown

Registered

2016-12-22

Start date

2017-01-23

Completion date

Unknown

Last updated

2017-09-04

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

Conditions

Actinic keratosis MedDRA version: 19.0 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Allergy to constituents of the used medication (Metvix) Pregnancy or breastfeeding Patients with known hypersensitivity to sunlight Patients not believed 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: To investigate how fast PpIX is produced in curetted and non-curetted skin. ;Secondary Objective: Not applicable ;Primary end point(s): How long time after Metvix application at non-curetted skin are formed as much PpIX as in curetted skin 3 hours after 30 minutes of Metvix application .;Timepoint(s) of evaluation of this end point: At the following timepoints after Metvix application: 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours and 6 hours	—

Measure

Time frame

Main Objective: To investigate how fast PpIX is produced in curetted and non-curetted skin. ;Secondary Objective: Not applicable ;Primary end point(s): How long time after Metvix application at non-curetted skin are formed as much PpIX as in curetted skin 3 hours after 30 minutes of Metvix application .;Timepoint(s) of evaluation of this end point: At the following timepoints after Metvix application: 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours and 6 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactDepartment of Dermatology, D92

Bispbjerg hospital

hans.christian.olsen.wulf@regionh.dk

Outcome results

None listed

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