Study of Topical Tirbanibulin Effectiveness and Safety for Treating Actinic Keratoses with Specific Proliferation Patterns

What this Trial Is About

This research aims to observe how tirbanibulin affects the growth patterns of actinic keratoses AK, which are precancerous skin changes often caused by UV exposure. The study focuses on using a special score called the PRO score to measure cell proliferation in these lesions. Actinic keratoses are common and can be challenging to treat due to their tendency to persist or recur. This study evaluates tirbanibulins role in treating AK with specific cell growth patterns and monitors local skin reactions to assess tolerability. Participants will apply tirbanibulin topically according to its approved use. The treatment involves five consecutive applications, which is considered quick and generally causes minor local reactions. Proliferation and clearance of the lesions will be measured using an imaging technique called line-field optical coherence tomography LC-OCT at different time points, including 14 days and 70 days after treatment start. Optionally, tissue samples may be examined after treatment to further assess histological changes. During the study, participants will be assessed for changes in the PRO score and lesion clearance through LC-OCT and clinical evaluations at scheduled visits. Skin reactions will also be recorded to understand the treatments tolerability. The main outcome is the improvement or clearance of the marker lesion 70 days after inclusion. The study lasts about 70 days, with key evaluations at 14 and 70 days after starting treatment, ensuring thorough monitoring of treatment effects and safety.

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns