NCT05900258

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Tirbanibulin	Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.

Timeline

• Start date: 2023-05-11
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2023-06-12
• Last updated: 2023-11-14

Locations

1 site across 1 country: Austria