Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirbanibulin.
- Who it may be relevant to
- Registry conditions: Actinic Keratosis (AK). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Drug Tirbanibulin
Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days
Primary outcome measures
- Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area [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 [Time frame: At the end of study observation period, at day 57]
Secondary outcome measures (1)
- 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
Inclusion criteria
- Diagnosed with AK on the face.
- Has clinically typical, visible, and discrete 4-12 AK lesions on the face.
- Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK lesions on the face.
- Male or female, aged 18 years and above at the time of initiation of treatment with tirbanibulin.
- Willing to avoid excessive sun or UV exposure, and/or use relevant sunscreen protection and protective clothing during the study duration.
- Able to read and write in English.
- Provide consent to participate in the study.
- Willing to comply with all study procedures (including photography tasks) and be available for the duration of the study.
Exclusion criteria
- Patients with any dermatological condition of the face that could interfere with clinical evaluations.
- Hypertrophic AK lesions, open wounds, or suspected skin cancers within 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Ablon Skin Institute and Research Center — Manhattan Beach
- Dermatology & Laser Center of Charleston — Charleston
Identifiers
NCT: NCT07657988 · 2051-AH-AK-TN