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

NCT06644079 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-05-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • TXA Tech

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Bently Doonan, MD, MS · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06644079 on ClinicalTrials.gov