Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate patient reported outcomes (PROs) in terms of health-related quality of life (HRQoL) among subjects with actinic keratosis (AK).

Official Title
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A Prospective Cohort Study of Patients With Actinic Keratosis (AK) in the Face or Scalp Treated With Tirbanibulin and Followed for 24 Weeks Post Treatment-initiation. Patient Reported Outcomes (PROs) and Clinical Profile of Patients Will be Gathered for Descriptive Analyses of Patient Outcomes Over the 24-week Study Observation Period

Conditions
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Keratosis, Actinic

Intervention / Treatment
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* Drug: Tirbanibulin (Klisyri®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Actinic Keratosis (AK) of the face or scalp Has clinically typical, visible, and discrete AK lesions Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK Willing to avoid excessive sun or ultraviolet (UV) exposure, and/or use relevant sunscreen protection and protective clothing during the study duration Able to read and write English Provide consent to participate in the study Willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Patients with any dermatological condition of the face or scalp that could interfere with the clinical evaluations. Hypertrophic AK lesions, open wounds or suspected skin cancers within close 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tirbanibulin (Klisyri®)<br>Participants will receive tirbanibulin ointment 2.5 mg in 250 mg (single dose packet). The participants will be observed for 24 weeks to gather participant reported outcomes (PROs) and clinical profile. | Drug: Tirbanibulin (Klisyri®)<br>* Participants will be treated with tirbanibulin ointment 1% (2.5 mg tirbanibulin in 250 mg) as 1 single-dose packet per application, for 5 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Skindex-16 Questionnaire Score | Skindex is the dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with Investigator Global Assessment (IGA) Success | IGA success defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of Actinic Keratosis (AK) status at Week 8 | Week 8 |