Optimized photodynamic therapy for skin cancer

Optimized photodynamic therapy for basal cell carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002508-16-DK

Enrollment

Registered

2016-07-06

Start date

2016-08-31

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

Basal cell carcinoma MedDRA version: 19.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream INN or Proposed INN: Methyl aminolevulinate Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: mg/g milligram(s)/gram Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Primary cell carcinoma (25 superficial and 25 nodular) which have been verified by biopsy - Up to 3 basal cell carcinoma pr. patient - 18 years or older - Informed written and oral consent - Fertile women have to use safe contraceptive measures 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 30

Exclusion criteria

Exclusion criteria: - Basal cell carcinoma localized on the tip of the nose, eyelid, ears, lips, scalp and feet - Basal celle carcinoma > 6 mm thick based on clinical examination - Recurrent tumors - Basal cell carcinom of mophea and infiltrative subtype - Organtransplanted patients - Allergy to the constituents of the used medication - Patients not believed to be able to follow protocol - Pregnancy or breastfeediing

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the effect of 3 treatment sessions with PDT in treatment of basal cell carcinoma;Secondary Objective: Investigate adverse events: Hyper/hypopigmentation Cosmetic outcome;Primary end point(s): Complete clearance of tumor. It is assessed whether the tumor has completely disappeared after treatment (complete response) or not completely disapperared (non-complete response) Recurrence rate;Timepoint(s) of evaluation of this end point: Complete clearance of tumor: 3 months after last treatment Recurrence rate: 6 and 12 months after last treatment	—

Measure

Time frame

Main Objective: Investigate the effect of 3 treatment sessions with PDT in treatment of basal cell carcinoma;Secondary Objective: Investigate adverse events: Hyper/hypopigmentation Cosmetic outcome;Primary end point(s): Complete clearance of tumor. It is assessed whether the tumor has completely disappeared after treatment (complete response) or not completely disapperared (non-complete response) Recurrence rate;Timepoint(s) of evaluation of this end point: Complete clearance of tumor: 3 months after last treatment Recurrence rate: 6 and 12 months after last treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Hyper/hypopigmentation Cosmetic outcome;Timepoint(s) of evaluation of this end point: 3,6 and 12 months after last treatment	—

Countries

Denmark

Contacts

Public ContactDepartment of Dermatology D92

Bispebjerg Hospital

h.wulf@regionh.dk

Outcome results

None listed

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