Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR) (NCT07657988) | Clinical Trial Compass
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Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
United States30 participantsStarted 2026-04-02
Plain-language summary
The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is:
How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period.
Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with AK on the face.
* Has clinically typical, visible, and discrete 4-12 AK lesions on the face.
* Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK lesions on the face.
* Male or female, aged 18 years and above at the time of initiation of treatment with tirbanibulin.
* Willing to avoid excessive sun or UV exposure, and/or use relevant sunscreen protection and protective clothing during the study duration.
* Able to read and write in English.
* Provide consent to participate in the study.
* Willing to comply with all study procedures (including photography tasks) and be available for the duration of the study.
Exclusion Criteria:
* Patients with any dermatological condition of the face that could interfere with clinical evaluations.
* Hypertrophic AK lesions, open wounds, or suspected skin cancers within proximity of the treatment area.
* Anticipated need for in-patient hospitalization or in-patient surgery within the next 2 months.
* Patients unable to comply with the requirements of the study or patients who, in the opinion of the study physician should not participate in the study.
* Patients for whom medical chart is inaccessible to physicians to complete baseline data collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area
Timeframe: At end of study observation period, at day 57
2
Subject and clinician rating of their satisfaction with the ability of tirbanibulin treatment to 'improve how skin looks' and 'improve skin texture' respectively, in the original AK treated area
Timeframe: At the end of study observation period, at day 57