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

Almirall, S.A.300 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Keratosis, Actinic

Interventions

TirbanibulinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with 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: * Participants 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. * Participants unable to comply with the requirements of the study or participants who in the opinion of the study physician should not participate in the study. * Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Locations (1)

Almirall Investigational Site 1

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8

Skindex-16 is a validated dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The Skindex-16 consisted of 16 items that were divided into three domains: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular Quality of life assessment.

Time frame: Baseline, Week 8

Secondary Outcomes

Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8

IGA success was defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of AK status at Week 8. The IGA is 5-point scale that assessed the severity of actinic keratosis, with scores ranged from 0 (completely clear) to 4 (not cleared): 0 = completely cleared (100% clearance); 1 = partially cleared (\>=75% clearance); 2 = moderately cleared (50% to 74% clearance); 3 = minimally cleared (\<50% clearance); 4 = not cleared (0% clearance), where higher score indicated higher severity.

Time frame: At Week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.