Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Kera… (NCT05260073) | Clinical Trial Compass
CompletedNot Applicable
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
United States300 participantsStarted 2022-03-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8