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

NCT05260073 | Completed Results

• 1 other identifier: M-14789-43
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Keratosis, Actinic

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 8

Secondary Outcomes (1)

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

  At Week 8

Study Arms (1)

Tirbanibulin

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.

Drug: Tirbanibulin

Interventions

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.

Also known as: Klisyri®

Tirbanibulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be participants diagnosed with AK on the face or scalp, and aged 18 years or above at the time of initiation of treatment. The study cohort will be drawn from dermatology clinics from across the U.S.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Almirall Investigational Site 1

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• Berman B, Armstrong A, Lebwohl M, Grada A, Bhatia N, Patel VA, Rigel D, Del Rosso J, Schlesinger T, Kircik L, Salem R, Narayanan S, Kasujee I. Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel. JAAD Int. 2023 Sep 23;16:192-198. doi: 10.1016/j.jdin.2023.09.006. eCollection 2024 Sep.

  PMID: 39040844 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

tirbanibulin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A.

rd@almirall.com

+34932913000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: March 9, 2022
• Primary Completion: October 31, 2022
• Study Completion: March 7, 2023
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)