Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 face or scalp
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18 years
• Histologically confirmed,
• primary, previously untreated,
• superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis)
Locations
Other Locations
France
CHU de Nice - Hôpital de l'Archet
RECRUITING
Nice
Contact Information
Primary
Philippe Bahadoran, PhD
bahadoran.p@chu-nice.fr
+33492036223
Backup
Henri Montaudie, PhD
+33492036223
Time Frame
Start Date: 2024-02-16
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Experimental : 5 Day treatment course 1 with Tirbanibulin Ointment 1%
Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days. Subjects with unresolved lesion at d28 or d56 or d72 or d84 will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice