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

NCT07657988 | Recruiting FDA Drug

• 1 other identifier: 2051-AH-AK-TN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the end of study observation period, at day 57

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

  At the end of study observation period, at day 57

Study Arms (1)

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.

Drug: Tirbanibulin

Interventions

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

Also known as: Klisyri®

Tirbanibulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avant Health LLC: lead

Study Sites (2)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

RECRUITING

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29414, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic; Personal Satisfaction

Interventions

tirbanibulin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Siva Narayanan, PhD, MPhil, MHS, MSc

  Avant Health LLC

  STUDY CHAIR

• Todd Schlesinger, MD

  Avant Health LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siva Narayanan, PhD, MPhil, MHS, MSc

CONTACT

301-799-AVANT; info@avant-health.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 18, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)