Overview

Combination 5-FU / Calcipotriene Cream for SCCIS/SCC

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
The study will determine if calcipotriene and 5-fluorouracil (5-FU) creams when combined can treat SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC). 30 Patients will be divided into a 7 day treatment group (n=10), a 14 day treatment group (n=10), and a placebo group (n=10, divided into 7 and 14 days evenly). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives.
Phase:
Early Phase 1
Details
Lead Sponsor:
Carilion Clinic
Treatments:
Calcipotriene
Fluorouracil