Patient and Clinician Reported Outcomes… | Clinical Trial

Key information

Conditions

Keratosis, Actinic Keratosis Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Almirall Investigational Site 1

Charleston, South Carolina, 29401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirbanibulin

Drug

Participants will be treated with tirbanibulin ointment 1% (2.5 mg tirbanibulin in 250 mg) as 1 single-dose packet per application, for 5 consecutive days.

Other names: Klisyri®

Primary outcomes

Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8

Time frame: Baseline, Week 8

Skindex-16 is a validated dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The Skindex-16 consisted of 16 items that were divided into three domains: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular Quality of life assessment.

Secondary outcomes

Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8

Time frame: At Week 8

IGA success was defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of AK status at Week 8. The IGA is 5-point scale that assessed the severity of actinic keratosis, with scores ranged from 0 (completely clear) to 4 (not cleared): 0 = completely cleared (100% clearance); 1 = partially cleared (>=75% clearance); 2 = moderately cleared (50% to 74% clearance); 3 = minimally cleared (<50% clearance); 4 = not cleared (0% clearance), where higher score indicated higher severity.

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

A 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

Acronym: PROAK

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Mar 2, 2022
Registry last updated: Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed