NCT05260073

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tirbanibulin	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.

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-10-31
• Completion: 2023-03-07
• First posted: 2022-03-02
• Last updated: 2024-09-20
• Results posted: 2024-09-20

Locations

1 site across 1 country: United States