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Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults

NCT05713760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-07-19

No results posted yet for this study

Summary

This is a Phase 2, Single-Arm, Open-Label, Single Center, Proof of Concept Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp).

Conditions

  • Superficial Basal Cell Carcinoma

Interventions

DRUG

Tirbanibulin Ointment 1%

Klisyri® ointment is a microtubule inhibitor for topical use and is currently on the market for the treatment of actinic keratosis of the face or scalp. The chemical name of tirbanibulin is N-benzyl-2-(5-(4-(2- morpholinoethoxy)phenyl)pyridin-2-yl) acetamide. Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol and is supplied in packets containing 250 mg of tirbanibulin ointment 1%. Each packet includes single-dose packets (2.5 mg tirbanibulin in 250 mg) to be applied to evenly cover up to 25 cm² of the treatment field once daily for 5 consecutive days using 1 single-dose packet per application.

Sponsors & Collaborators

  • Austin Institute for Clinical Research

    lead NETWORK

Principal Investigators

  • Edward Lain, MD, MBA · Austin Institute for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-03-07
Completion
2024-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05713760 on ClinicalTrials.gov