RecruitingNCT07657988

Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)

Patient and Clinician Reported Outcomes Among Patients With Actinic Keratosis Receiving Tirbanibulin for Large fiEld Application on the Face, in U.S Clinical pRactice Settings: A Pilot Initiative (CLEAR)


Sponsor

Avant Health LLC

Enrollment

30 participants

Start Date

Apr 2, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTirbanibulin

Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days


Locations(2)

Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Dermatology & Laser Center of Charleston

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07657988


Related Trials