NCT06644079

Window of Opportunity Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma

Window of Opportunity Pilot Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tranexamic Acid (TXA) is a safe and effective antifibrinolytic drug used systemically to control bleeding and topically to treat melasma and rosacea. TXA suppresses the viability of multiple human/murine cancer cell lines and Plasmin formation, which prevents cleavage of the CDCP1 protein to a more oncogenic form. TXA appears to act through additional anticancer mechanisms that include reduction of S6K1 and STAT3 phosphorylation on sites required for their activation. Uptake by cancer results in blockade of protein synthesis, and alter signaling through the amino acid-sensitive mTORC1/S6K1 and GCN2/eiF2a/ATF4 pathways. This is expected to induce autophagy, which may mediate some of the biological effects of TXA on cells. This effect of TXA is expected to be most prominent in cells that rely on high levels of basal protein synthesis such as cancer cells. Currently no clinical treatment in this space to spare or improve surgical outcomes. Positive results could help reduce tumor size and suppress new cancer cell production before surgical interventions are taken. This treatment could improve the outcomes and treatments of people with skin cancer. If this window study is successful further studies will focus on patients with unresectable disease or those with lesions in areas difficult for surgical intervention.

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Participants will self-apply topical tranexamic acid to the area where their disease is located 3 times daily for 21-28 days prior to their scheduled Moh's or excision surgery.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-10-16
• Last updated: 2025-05-02

Regulatory

• FDA-regulated drug study