Daylight photodynamic therapy for premalignant skin cancer lesions: a comparison of two light sensitizing creams

Daylight photodynamic therapy for actinic keratoses: a multicentre study comparing two photosensitizers (BF-200 ALA versus MAL)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000265-32-FI

Enrollment

Registered

2015-03-06

Start date

2015-04-08

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

Actinic keratosis

Interventions

Trade Name: Ameluz Pharmaceutical Form: Cream CAS Number: 106-60-5 Other descriptive name: AMINOLEVULINIC ACID Trade Name: Metvix Pharmaceutical Form: Cream Other descriptive name: METHYL AMINOLEVULI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with with widespread actinic keratosis lesions symmetrically on face or scalp (at least 3 actinic keratoses symmetrically on face or scalp). 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: Previous treatment for actinic keratosis on the same skin area during preceding 6 months. Porfyria or solar dermatitis. Allergy for photosensitizers used in study. Pregnant or breastfeeding patients. Impaired general condition (patient can't manage required 2 hours in sunlight outdoors).

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare BF-200 ALA's (Ameluz) and MAL's (Metvix) efficacy on actinic keratoses in daylight photodynamic therapy. Result of the treatment is assessed with clinical examination 3 and 12 months after treatment.;Secondary Objective: To compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.;Primary end point(s): Clinical curing of the actinic keratosis lesions;Timepoint(s) of evaluation of this end point: 3 and 12 months	—

Measure

Time frame

Main Objective: To compare BF-200 ALA's (Ameluz) and MAL's (Metvix) efficacy on actinic keratoses in daylight photodynamic therapy. Result of the treatment is assessed with clinical examination 3 and 12 months after treatment.;Secondary Objective: To compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.;Primary end point(s): Clinical curing of the actinic keratosis lesions;Timepoint(s) of evaluation of this end point: 3 and 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): To investigate if total daylight dose received by patient affects the efficacy of treatment.;Timepoint(s) of evaluation of this end point: 3 and 12 months	—

Countries

Finland

Contacts

Public ContactJanne Räsänen

Janne Räsänen

jaerasan@student.uef.fi+358503777145

Outcome results

None listed

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