Status:
RECRUITING
Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 fac...
Detailed Description
This is a pilot study aimed at studying the efficacy and tolerance of a new topical treatment regimen in BCC. The number of 50 sBCC to be treated was established based on previous studies that have in...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically confirmed,
- primary, previously untreated,
- superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)
Exclusion
- BCC of the face or scalp
- BCC of non-superficial subtype
- BCC with large axis \> 15mm
- Relapsing BCC
- Allergy to treatment
- Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06112522
Start Date
February 16 2024
End Date
December 1 2025
Last Update
March 18 2024
Active Locations (1)
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1
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, France, 06200