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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirbanibulin | Participants will receive tirbanibulin ointment 3.5 mg in 350 mg (as 1 single-dose packet per application, for 5 consecutive days). The participants will be observed for 57 days to gather participant reported outcomes (PROs) and clinical profile. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirbanibulin | Drug | Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At the end of study observation period, at day 57 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siva Narayanan, PhD, MPhil, MHS, MSc | Contact | 301-799-AVANT | info@avant-health.com |
| Name | Affiliation | Role |
|---|---|---|
| Siva Narayanan, PhD, MPhil, MHS, MSc | Avant Health LLC | Study Chair |
| Todd Schlesinger, MD | Avant Health LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ablon Skin Institute and Research Center | Recruiting | Manhattan Beach | California | 90266 | United States |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000713668 | tirbanibulin |
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|
| Dermatology & Laser Center of Charleston | Recruiting | Charleston | South Carolina | 29414 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |