Status:
COMPLETED
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
Lead Sponsor:
Almirall, S.A.
Conditions:
Keratosis, Actinic
Eligibility:
All Genders
18+ years
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05260073
Start Date
March 9 2022
End Date
March 7 2023
Last Update
September 20 2024
Active Locations (1)
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1
Almirall Investigational Site 1
Charleston, South Carolina, United States, 29401