Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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)

NCT ID: NCT07657988Sponsor: Avant Health LLCLast updated: 2026-06-18

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.

Arms & 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

Outcome measures

Primary

  • Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area

    The overall appearance of the skin in the original AK treated area (in comparison to baseline) is rated on a 5-point Likert scale of much worse, somewhat worse, no change, somewhat improved, much improved.

    Time frame: At end of study observation period, at day 57

  • 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

    Satisfaction is rated on a 7-point Likert scale of extremely satisfied, very satisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied, extremely satisfied.

    Time frame: At the end of study observation period, at day 57

Secondary

  • Proportion of Subjects with IGA success, defined as an IGA score of completely cleared (0) or partially cleared (1) in AK status in the treated area

    Time frame: At the end of study observation period, at day 57

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (2)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266

Recruiting
Glynis Ablon, MD · Contact
Glynis Ablon, MD · Principal Investigator

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29414

Recruiting
Todd Schlesinger, MD · Contact
Todd Schlesinger, MD · Principal Investigator