A RANDOMIZED, MULTICENTER STUDY OF DAYLIGHT MEDIATED PHOTODYNAMIC THERAPY WITH METVIX® CREAM 160 mg/g IN PATIENTS WITH MULTIPLE ACTINIC KERATOSIS ON THE FACE AND SCALP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000991-26-DK

Enrollment

150

Registered

2008-03-25

Start date

2008-04-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Actinic keratoses MedDRA version: 9.1 Level: LLT Classification code 10000614 Term: Actinic keratosis

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream CAS Number: 79416-27-6 Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: % (W/W) percent weight/weight Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females above 18 years of age. Clinical diagnosis of at least 5 aktinic keratoses on the face and/or scalp within an area of at least 25 cm2. Written informed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients using immunosuppressive medication. Woman of child-bearing potential.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the patient resonse rate of Metvix-photodynamic therapy after 1.5 hours or 2.5 hours daylight exposure at 3 months after treatment;Secondary Objective: To investigate the relationship between the total light dose and patient response rate and the occurence and severity of local phototoxic reactions like pain, erythema and pustular eruption during and and at defined time points after treatment;Primary end point(s): Patient response rate 3 months after Metvix-photodynamic therapy. Patient response rate is defined as number of lesions in complete resonse in a patient divided by the number of lesions within the patient at baseline.	—

Measure

Time frame

Main Objective: To compare the patient resonse rate of Metvix-photodynamic therapy after 1.5 hours or 2.5 hours daylight exposure at 3 months after treatment;Secondary Objective: To investigate the relationship between the total light dose and patient response rate and the occurence and severity of local phototoxic reactions like pain, erythema and pustular eruption during and and at defined time points after treatment;Primary end point(s): Patient response rate 3 months after Metvix-photodynamic therapy. Patient response rate is defined as number of lesions in complete resonse in a patient divided by the number of lesions within the patient at baseline.

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Countries

Denmark, Sweden

Outcome results

None listed

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