Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
ConditionActinic Keratosis (AK)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAvant Health LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tirbanibulin
DrugParticipants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Tirbanibulin1 intervention
Trial outcomes
Primary outcomes
1
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 572
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 57Secondary outcomes
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 57Sponsors and contacts
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Source ClinicalTrials.gov