Completed
PROAKA 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
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Keratosis+3
+ Neoplasms
+ Precancerous Conditions
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: March 2022
Summary
Principal SponsorAlmirall, S.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 9, 2022
Actual date on which the first participant was enrolled.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).
Official TitleA 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
Principal SponsorAlmirall, S.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
KeratosisNeoplasmsPrecancerous ConditionsSkin DiseasesSkin and Connective Tissue DiseasesKeratosis, Actinic
Criteria
7 inclusion criteria required to participate
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
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5 exclusion criteria prevent from participating
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Almirall Investigational Site 1
Charleston, United StatesOpen Almirall Investigational Site 1 in Google MapsCompletedOne Study Center