N/A
Completed N=300
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
Keratosis, Actinic
Source: ClinicalTrials.gov NCT05260073 ↗
Enrolled (actual)
300
Serious AEs
2.0%
Results posted
Sep 2024
Primary outcomePrimary: Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 — 22.30; -14.26; 38.17; -24.88 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8 |
22.30; -14.26; 38.17; -24.88; 14.41; -9.78 | — |
| SECONDARY Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8 |
73.79 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05260073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.