Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis (PROAK)

Almirall

Status: Completed

Conditions: Keratosis, Actinic

Treatments: Drug: Tirbanibulin

Study type: Observational

Funder types: Industry

Identifiers

NCT05260073

M-14789-43

Details and patient eligibility

About

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).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

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.

Treatment:

Drug: Tirbanibulin