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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
    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®

Recruiting Locations

Ablon Skin Institute and Research Center
Manhattan Beach, California 90266
Contact:
Glynis Ablon, MD
310-727-3376
drablon@abloninstitute.com

Dermatology & Laser Center of Charleston
Charleston, South Carolina 29414
Contact:
Todd Schlesinger, MD
843.377.2201
skindoc@dermandlaser.com

More Details

Status
Recruiting
Sponsor
Avant Health LLC

Study Contact

Siva Narayanan, PhD, MPhil, MHS, MSc
301-799-AVANT
info@avant-health.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.