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

Patients will receive ablative fractional laser (AFL)-assisted cisplatin+5-fluorouracil (5-FU) as a treatment for their cutaneous basal cell carcinoma (BCC). In brief, treatment areas consisting of tumors and a 5 mm margin will undergo AFL exposure (CO2 laser) followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) at a dose of 0.25 ml per cm2. After removal of cisplatin, a commercially distributed 5-FU cream (5% Efudix®) 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.

Outcome measures and methods/techniques are summarized below.

Primary outcome:

To investigate tolerability of topical AFL-assisted cisplatin+5-FU therapy for BCC by evaluating:

I. Severity and duration of clinical local skin reactions including erythema, edema, scabbing, flaking and pustulation assessed by a physician using an established 0-4 point scale (none, mild, moderate, severe) from 0-30 days post-treatment.

II. Occurrence of side effects (prolonged erythema/edema, hyper/hypopigmentation, scarring and infection) up to 3 months post-treatment.

Secondary outcome:

• To monitor BCC tumor size and clearance based on clinical assessments and dermoscopy, supported by non-invasive imaging techniques including dynamic optical coherence tomography (D-OCT), reflectance confocal microscopy (RCM), high intensity focused ultrasound (HIFU) and histological analysis up to 3 months post-treatment.

Inclusion criteria

• Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
• >18 years of age at baseline
• Legally competent, able to give verbal and written informed consent
• Subject in good general health, is willing to participate and can comply with protocol requirements.
• Fitzpatrick skin phototype I-III
• Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

Exclusion criteria

• High-risk BCC i. Tumors in the following anatomical locations: midface, orbital, ears ii. Size: >20 mm in facial/scalp areas or > 50 mm in non-facial/non-scalp areas iii. Subtype: morpheaform and micronodular BCC iv. History: Gorlin syndrome or immunosuppression
• Previous treatment of the BCC lesion
• Known allergy to cisplatin or Efudix®
• Other skin diseases present in the treatment area
• Tattoo in the treatment area which may interfere with or confound evaluation of the study
• History of keloids which is deemed clinically relevant in the opinion of the investigator
• Fitzpatrick skin phototype IV-VI
• Lactating or pregnant women