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NCT Number: NCT07657988

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

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.

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Key information

Conditions

Actinic Keratosis (AK) Behavior Keratosis Keratosis, Actinic Neoplasms Personal Satisfaction Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ablon Skin Institute and Research Center, Manhattan Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirbanibulin

Drug

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

Other names: Klisyri®

Primary outcomes

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

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

    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.

  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

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

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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Siva Narayanan, PhD, MPhil, MHS, MSc

CONTACT

[email protected]

301-799-AVANT

Sponsors and collaborators

Lead sponsor

Avant Health LLC

Other

Registry information

Official study title

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)

Acronym: CLEAR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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