Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 9, 2018

Primary Completion Date

September 2, 2019

Study Completion Date

September 2, 2019

Conditions
Carcinoma, Basal Cell
Interventions
DRUG

AFL-assisted cisplatin+5-FU

Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30.

Trial Locations (1)

2400

Department of Dermatology, Bispebjerg Hospital, Copenhagen

All Listed Sponsors
lead

Merete Haedersdal

OTHER

NCT03541252 - Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study | Biotech Hunter | Biotech Hunter