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

• Status: Completed
• Trial end date: 2019-09-02
• Target enrollment: 0
• Participant gender: All

Summary

A prospective clinical, uncontrolled, open-label, explorative phase IIa trial on patients with histologically- confirmed superficial and nodular basal cell carcinoma (BCC) . The study assesses tolerability and tumor clearance after laser-assisted topical delivery of two synergistic chemotherapeutic agents, cisplatin and 5-fluorouracil (5-FU) in BCC patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merete Haedersdal
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk

2. >18 years of age at baseline

3. Legally competent, able to give verbal and written informed consent

4. Subject in good general health, is willing to participate and can comply with protocol requirements.

5. Fitzpatrick skin phototype I-III

6. Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

Exclusion Criteria:

1. 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

2. Previous treatment of the BCC lesion

3. Known allergy to cisplatin or Efudix®

4. Other skin diseases present in the treatment area

5. Tattoo in the treatment area which may interfere with or confound evaluation of the study

6. History of keloids which is deemed clinically relevant in the opinion of the investigator

7. Fitzpatrick skin phototype IV-VI

8. Lactating or pregnant women