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

Conditions: Actinic keratosis
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-000265-32-FI

Lead Sponsor: Janne Räsänen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Clinical curing of the actinic keratosis lesions;Timepoint(s) of evaluation of this end point: 3 and 12 months;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.

Secondary Outcome Measures

Name	Time	Method
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