Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
Status:
Recruiting
Trial end date:
2024-05-31
Target enrollment:
Participant gender:
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.