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

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2015-000265-32-FI
• Date of registration: 06/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janne Räsänen
• Public title: Daylight photodynamic therapy for premalignant skin cancer lesions: a comparison of two light sensitizing creams
• Scientific title: Daylight photodynamic therapy for actinic keratoses: a multicentre study comparing two photosensitizers (BF-200 ALA versus MAL)
• Date of first enrolment: 08/04/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000265-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: Janne Räsänen
• Affiliation: Janne Räsänen

• Name: Janne Räsänen
• Affiliation: Janne Räsänen

Key inclusion & exclusion 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:
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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Actinic keratosis

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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 AMINOLEVULINATE HYDROCHLORIDE

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 3 and 12 months

Secondary Objective: To compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.

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.

Primary end point(s): Clinical curing of the actinic keratosis lesions

Secondary Outcome(s)

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

Secondary ID(s)

Q282dnro3/2015

Source(s) of Monetary Support

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