Clinical trial · Observational
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
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
NCT05260073CI-TRIAL-00080935PROAKcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirbanibulin | Drug | Tirbanibulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tirbanibulin
- description
- 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.
- interventionNames
- Drug: Tirbanibulin
Primary outcomes (1)
- measure
- Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8
- timeFrame
- Baseline, Week 8
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBerman B, Armstrong A, Lebwohl M, Grada A, Bhatia N, Patel VA, Rigel D, Del Rosso J, Schlesinger T, Kircik L, Salem R, Narayanan S, Kasujee I. Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel. JAAD Int. 2023 Sep 23;16:192-198. doi: 10.1016/j.jdin.2023.09.006. eCollection 2024 Sep. PMID 39040844