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Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Study acronym: Tirbaso
StatusRecruiting
PhasePhase 2
Started2024-02-16
View on ClinicalTrials.gov ↗

Amendment history

2026-06-18
Study Status v2
Primary completion date2024-12-01→2027-12-16
Completion date2025-12-01→2027-12-16
2024-03-15
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12-01→confirmed 2024-02-16
Secondary endpoints3 entries, revised
To evaluate the safetyNumber of TirbanibulinParticipants (Klisiry®)With inTreatment-Related sBCCAdverse Events as Assessed by CTCAE v4.0 To evaluate the efficacyNumber of TirbanibulinParticipants (Klisiry®)With incomplete sBCC after the 1st, 2nd, 3rd, or 4th cycleremission Number of tirbanibulin. Toparticipants evaluatewith sBCC thickness.
Primary endpoints1 entry, revised
Safety and TolerabilityIncidence of Klisiry®Treatment-Emergent Adverse Events
Study sitesdetails revised at 1 of 1 site
2023-10-27
Original filing
his is a Phase 2, Single-Arm, Open-Label, Single Center, to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) not arising on the face or scalp
Trial Details
NCT Number NCT06112522
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Cell Carcinoma
Enrollment 50 participants
Start Date 2024-02-16
Primary Completion 2027-12-16 (estimated)
Study Completion 2027-12-16 (estimated)
Updated on ClinicalTrials.gov 2026-06-22