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Study identifier: NCT03370406 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

Condition: Carcinoma, Squamous Cell  ·  Sponsor: Melissa Pugliano-Mauro

PhasePhase 1
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 0.005% calcipotriene cream to kill topically accessible SCC cells. The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.

This description comes directly from the study's public registry record.

Talk to the study team

Melissa Pugliano-Mauro, MD  ·  (412) 996-6428  ·  puglianomauroma@upmc.edu

Jeff Plowey, MS  ·  (412) 724-7375  ·  ploweyjm2@upmc.edu

Always discuss trial participation with your own doctor first.

Locations (1)

St. Margaret Hospital DermatologyPittsburgh, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03370406