Recruiting

Tirbanibulin

Sponsor:

Avant Health LLC

Code:

NCT07657988

Conditions

Actinic Keratosis (AK)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirbanibulin

Study Details

Brief 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.

Conditions

Actinic Keratosis (AK)

Study ID

NCT07657988

Start date

Apr 2, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Tirbanibulin

Participants will receive tirbanibulin ointment 3.5 mg in 350 mg (as 1 single-dose packet per application, for 5 consecutive days). The participants will be observed for 57 days to gather participant reported outcomes (PROs) and clinical profile.

Interventions

Tirbanibulin

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Siva Narayanan, PhD, MPhil, MHS, MSc

301-799-AVANTinfo@avant-health.com

Locations

Ablon Skin Institute and Research Center

Recruiting

Manhattan Beach, California, United States, 90266

Contacts

Glynis Ablon, MD

310-727-3376drablon@abloninstitute.com

Principal Investigator:

Glynis Ablon, MD

Dermatology & Laser Center of Charleston

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Todd Schlesinger, MD

843.377.2201skindoc@dermandlaser.com

Principal Investigator:

Todd Schlesinger, MD

More Information

Sponsor

Avant Health LLC

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • tirbanibulin
  • Actinic Keratosis
  • Overall Appearance
  • Skin Texture
  • Skin Quality
  • IGA
  • Satisfaction
  • Preference

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Avant Health LLC on 2026-06-18.