Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
- Registration Number
- NCT05260073
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tirbanibulin Tirbanibulin 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 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.
Trial Locations
- Locations (1)
Almirall Investigational Site 1
🇺🇸Charleston, South Carolina, United States