Actinic Keratosis (AK)
Conditions
Keywords
tirbanibulin, Actinic Keratosis, Overall Appearance, Skin Texture, Skin Quality, IGA, Satisfaction, Preference
Brief 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.
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
Sponsors
Avant Health LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area | At end of study observation period, at day 57 | 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. |
| 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 | At the end of study observation period, at day 57 | Satisfaction is rated on a 7-point Likert scale of extremely satisfied, very satisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied, extremely satisfied. |
Secondary
| Measure | Time frame |
|---|---|
| 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 | At the end of study observation period, at day 57 |
Countries
United States
Contacts
CONTACTSiva Narayanan, PhD, MPhil, MHS, MSc
STUDY_CHAIRSiva Narayanan, PhD, MPhil, MHS, MSc
Avant Health LLC
PRINCIPAL_INVESTIGATORTodd Schlesinger, MD
Avant Health LLC
Outcome results
None listed