Patient and Clinician Reported Outcomes Among Patients With Actinic Keratosis Receiving Tirbanibulin for Large fiEld Application on the Face, in U.S Clinical pRactice Settings: A Pilot Initiative (CLEAR)
Summary
The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is: How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period. Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57.
Arms & interventions
- DrugTirbanibulin
Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days
Outcome measures
Primary
Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area
The overall appearance of the skin in the original AK treated area (in comparison to baseline) is rated on a 5-point Likert scale of much worse, somewhat worse, no change, somewhat improved, much improved.
Time frame: At end of study observation period, at day 57
Subject and clinician rating of their satisfaction with the ability of tirbanibulin treatment to 'improve how skin looks' and 'improve skin texture' respectively, in the original AK treated area
Satisfaction is rated on a 7-point Likert scale of extremely satisfied, very satisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied, extremely satisfied.
Time frame: At the end of study observation period, at day 57
Secondary
Proportion of Subjects with IGA success, defined as an IGA score of completely cleared (0) or partially cleared (1) in AK status in the treated area
Time frame: At the end of study observation period, at day 57
Eligibility criteria
Study locations (2)
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414