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

Keratosis, Actinic Clinical Trial

— PROAK  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260073
• Other study ID #: M-14789-43
• Status: Completed
• Start date: March 9, 2022
• Est. completion date: March 7, 2023

Study information

• Verified date: July 2023
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 7, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Actinic Keratosis (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:

• Patients 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.

• Patients unable to comply with the requirements of the study or patients who in the opinion of the study physician should not participate in the study.

• Patients for whom medical chart is inaccessible to physicians to complete baseline data collection.

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Tirbanibulin (Klisyri®)
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

Locations

Country	Name	City	State
United States	Almirall Investigational Site 1	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Skindex-16 Questionnaire Score	Skindex is the dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100.	Week 8
Secondary	Proportion of Participants with Investigator Global Assessment (IGA) Success	IGA success defined as achieving a rating of 'completely cleared' (0) or 'partially cleared' (1) in IGA of Actinic Keratosis (AK) status at Week 8	Week 8