Optimized photodynamic therapy for skin cancer

Phase 1

Active, not recruiting

Conditions: Basal cell carcinoma
MedDRA version: 19.0Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-002508-16-DK

Lead Sponsor: Department of Dermatology D92, Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 50

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the effect of 3 treatment sessions with PDT in treatment of basal cell carcinoma;Secondary Objective: Investigate adverse events:<br>Hyper/hypopigmentation<br>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)<br><br>Recurrence rate;Timepoint(s) of evaluation of this end point: Complete clearance of tumor: 3 months after last treatment<br><br>Recurrence rate: 6 and 12 months after last treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Hyper/hypopigmentation<br>Cosmetic outcome;Timepoint(s) of evaluation of this end point: 3,6 and 12 months after last treatment