Actinic Keratosis (AK)CLEARNCT07657988
Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
An observational study of Actinic Keratosis (AK), run by Avant Health LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- Tirbanibulin
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414
Todd Schlesinger, MD, 843.377.2201, skindoc@dermandlaser.com
Todd Schlesinger, MD
- Recruiting
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Glynis Ablon, MD, 310-727-3376, drablon@abloninstitute.com
Glynis Ablon, MD
About this study
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)
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.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- Tirbanibulin
- Keywords
- tirbanibulin, Actinic Keratosis, Overall Appearance, Skin Texture, Skin Quality, IGA, Satisfaction, Preference
- Medical subject headings
- Keratosis, Actinic, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirbanibulinDrug
Also called Klisyri®
Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tirbanibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of study observation period, at day 57
Secondary 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
Measured: At the end of study observation period, at day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start2 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis (AK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avant Health LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siva Narayanan, PhD, MPhil, MHS, MSc, Study chair, Avant Health LLCTodd Schlesinger, MD, Principal investigator, Avant Health LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657988
- Sponsor's protocol ID
- 2051-AH-AK-TN
- Acronym
- CLEAR
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07657988
- Acronym / sponsor ID
- CLEAR / 2051-AH-AK-TN
- Conditions
- Actinic Keratosis (AK)
- Keywords
- tirbanibulin, Actinic Keratosis, Overall Appearance, Skin Texture, Skin Quality, IGA, Satisfaction, Preference
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Avant Health LLCUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirbanibulin | – | Drug: TirbanibulinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirbanibulinAlso: Klisyri®Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days | Drug | Tirbanibulin |
Primary outcome
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
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
Time frame: 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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siva Narayanan, PhD, MPhil, MHS, MSc study chair
Avant Health LLC
Todd Schlesinger, MD principal investigator
Avant Health LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis (AK), run by Avant Health LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siva Narayanan, PhD, MPhil, MHS, MSc (301-799-AVANT, info@avant-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.