Keratosis, ActinicPhase 3TirbAKareNCT06135415
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
A Phase 3 study testing Tirbanibulin in people with Keratosis, Actinic, run by Almirall, S.A. at 35 sites in 5 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm^2) and up to 100 cm^2 in adult participants with actinic keratosis (AK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Tirbanibulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 21 Dec 2023to 25 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Participants having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that contains >= 4 to less than or equal to (<=) 12 clinically typical, visible, and discrete (non-confluent) AK lesions and measures more than 25 cm2 (example, one cheek) and up to approximately 100 cm2 (example, mid face).
- Participants willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
- Women of childbearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months prior to screening) must have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, be using highly effective methods of birth control for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, agree to have pregnancy tests while in the study and at the end of the study, and agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product.
- Sexually active males with female partners who are WOCBP must agree to use two forms of contraception, one of which must be barrier contraception, from screening through 90 days after their last dose of study treatment. All non-sterile male participants must agree not to donate sperm or attempt conception from screening through 90 days following their last dose of study treatment.
- Participants should have ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines.
Who cannot join
- Participants with clinically atypical and/or rapidly changing AK lesions in the TF; hyperkeratotic or hypertrophic lesions, recalcitrant disease (defined as failure to respond to cryosurgery on 2 previous occasions) and/or cutaneous horn; history of invasive SCC, Bowen's disease, BCC, or other malignant tumors in the TF; any other dermatological disease that causes difficulty with examination.
- Location of the TF is on any location other than the face or balding scalp, within 5 centimeter (cm) of an incompletely healed wound, within 5 cm of a suspected BCC or other neoplasms, periorbital, lips, or nostrils.
- Participants having a previous treatment with tirbanibulin 10 mg/g ointment.
- Females who are pregnant or nursing or seeking to become pregnant.
- Participants having intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication or therapy.
- Participants with anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 113.
Show all 12Show fewer
- Participants with history of sensitivity and/or allergy to any of the ingredients in the study medication.
- Participants with significant abnormalities on the medical history, physical examination (PE) findings, vital signs, clinical chemistry, or hematology results that in the judgment of the investigator may interfere with the interpretation of the results.
- Participants with skin disease (example; atopic dermatitis, psoriasis, eczema) or condition (example; scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evaluations, or which exposes the participant to unacceptable risk by study participation.
- Participants with significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the investigator, would expose the participant to unacceptable risk by study participation.
- Participants who have participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing in the current study.
- Participant who is employee or a relative to an employee at the research site or the Sponsor.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
Italy10 sites
Site 24
Bari
Site 25
Bologna
Site 19
Brescia
Site 26
Cagliari
Site 23
Florence
Site 22
Pisa
Site 27
Reggio Emilia
Site 20
Roma
Site 21
Roma
Site 7
Roma
Spain9 sites
Site 12
Barcelona
Site 14
Barcelona
Site 34
Barcelona
Site 33
Granada
Site 13
Madrid
Site 32
Salamanca
Site 15
Valencia
Site 35
Valencia
Site 16
Zaragoza
Germany8 sites
Site 17
Augsburg
Site 1
Bad Bentheim
Site 3
Bochum
Site 18
Dresden
Site 2
Hamburg
Site 5
Hamburg
Site 4
Mahlow
Site 6
Wuppertal
Poland6 sites
Site 31
Krakow
Site 30
Ossy
Site 10
Warsaw
Site 11
Warsaw
Site 9
Warsaw
Site 8
Wroclaw
About this study
Official title: A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis
The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm^2) and up to 100 cm^2 in adult participants with actinic keratosis (AK).
- Conditions
- Keratosis, Actinic
- Being tested
- Tirbanibulin, Vehicle ointment
- Keywords
- Actinic Keratosis, Keratosis, Keratosis, Actinic, Precancerous condition, Neoplasms, Sun Damaged Skin, Actinic Keratoses
- Medical subject headings
- Keratosis, Actinic, Keratosis, Precancerous Conditions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirbanibulinDrug
Also called Klisyri®
Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.
Vehicle ointmentOther
Participants will apply vehicle ointment topically on the face or balding scalp with AK.
| Study group | Role | What they receive |
|---|---|---|
| Tirbanibulin 10 mg/g | Experimental | Participants will apply tirbanibulin 10 mg/g ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve complete clearance (CC) at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85. Receives: Drug: Tirbanibulin |
| Vehicle ointment | Placebo comparator | Participants will apply vehicle ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve CC at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85. Receives: Other: Vehicle ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lesion Count at Day 57
Percent change from baseline in the AK lesion count at Day 57 was reported.
Measured: Baseline, Day 57
Secondary outcomes (7)
Percentage of Participants With Partial Clearance at Day 57
PC was defined as percentage of participants who achieved more than or equal to (>=) 75 percent (%) clearance of AK lesions in the Treatment field (TF) on the face or scalp at Day 57.
Measured: At Day 57
Percentage of Participants With Complete Clearance at Day 57
Complete clearance was defined as percentage of participants who achieved 100% clearance (no AK lesions) in the TF on the face or scalp at Day 57.
Measured: At Day 57
Percentage of Participants With Partial Clearance at Day 113
Percentage of of participants with partial clearance at Day 113, defined as 100% clearance in the TF at Day 57 or, for participants receiving a second treatment course, ≥75% clearance at Day 113
Measured: At Day 113
Percentage of Participants With Complete Clearance at Day 113
Percentage of participants with complete clearance by Day 113, defined as 100% clearance in the TF at Day 57 or, for participants receiving a second treatment course, 100% clearance at Day 113
Measured: At Day 113
Local Tolerability Signs Composite Score at Specific Timepoints
Local Tolerability Signs Composite Score was assessed as the sum of six individual tolerability signs-erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. Each sign was graded on a scale from 0 (none) to 3 (severe) with a total score range of 0 to 18. The higher score indicates worst tolerability.
Measured: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
Maximum Local Tolerability Signs Composite Score in Treatment Course
Maximum local tolerability signs composite score was assessed as the sum of six individual tolerability signs-erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. Each sign was graded on a scale from 0 (none) to 3 (severe) with a total score range of 0 to 18. The higher score indicates worst tolerability.
Measured: At Week 1 to 8 (Day 57) and Week 8 to 16 (Day 113)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest
An AE is defined as any untoward medical occurrence in a clinical trial participant, regardless of the administration of the IMP and its causal relationship to it. unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, or an abnormal finding in the physical examination. TEAE- AEs that occurred after the first administration of the IMP, either tirbanibulin or vehicle, during the study. An SAE is any untoward medical occurrence that at any dose resulted in death; is life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in participant hospitalization; congenital anomaly/birth defect or otherwise considered medically important. AESIs included skin cancers [including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma] appearing within or outside the TF during the study.
Measured: From Baseline up to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 Dec 2023
- Primary completion30 Apr 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135415
- Sponsor's protocol ID
- M-14867-33
- Other IDs
- 2023-505487-11-00, 2023
- Acronym
- TirbAKare
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2023
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT06135415
- Acronym / sponsor ID
- TirbAKare / M-14867-33
- Conditions
- Keratosis, Actinic
- Keywords
- Actinic Keratosis, Keratosis, Keratosis, Actinic, Precancerous condition, Neoplasms, Sun Damaged Skin, Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm^2) and up to 100 cm^2 in adult participants with actinic keratosis (AK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirbanibulin 10 mg/g | Experimental | Drug: TirbanibulinParticipants will apply tirbanibulin 10 mg/g ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve complete clearance (CC) at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85. |
| Vehicle ointment | Placebo comparator | Other: Vehicle ointmentParticipants will apply vehicle ointment once daily for 5 consecutive days beginning on Day 1. All participants will be evaluated for efficacy, safety, and tolerability at Day 8, 15, 29, and 57. Participants who do not achieve CC at Day 57 will receive a second 5-day course of the treatment. Participants receiving a second treatment course will also be evaluated for efficacy, safety, and tolerability at Day 64, 71, and 85. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that contains >= 4 to less than or equal to (<=) 12 clinically typical, visible, and discrete (non-confluent) AK lesions and measures more than 25 cm2 (example, one cheek) and up to approximately 100 cm2 (example, mid face).
- Participants willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
- Women of childbearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months prior to screening) must have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, be using highly effective methods of birth control for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, agree to have pregnancy tests while in the study and at the end of the study, and agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product.
- Sexually active males with female partners who are WOCBP must agree to use two forms of contraception, one of which must be barrier contraception, from screening through 90 days after their last dose of study treatment. All non-sterile male participants must agree not to donate sperm or attempt conception from screening through 90 days following their last dose of study treatment.
- Participants should have ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines.
Key exclusion criteria (12 listed)
- Participants with clinically atypical and/or rapidly changing AK lesions in the TF; hyperkeratotic or hypertrophic lesions, recalcitrant disease (defined as failure to respond to cryosurgery on 2 previous occasions) and/or cutaneous horn; history of invasive SCC, Bowen's disease, BCC, or other malignant tumors in the TF; any other dermatological disease that causes difficulty with examination.
- Location of the TF is on any location other than the face or balding scalp, within 5 centimeter (cm) of an incompletely healed wound, within 5 cm of a suspected BCC or other neoplasms, periorbital, lips, or nostrils.
- Participants having a previous treatment with tirbanibulin 10 mg/g ointment.
- Females who are pregnant or nursing or seeking to become pregnant.
- Participants having intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication or therapy.
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 will apply tirbanibulin ointment topically on the face or balding scalp with AK. | Drug | Tirbanibulin 10 mg/g |
| Vehicle ointmentParticipants will apply vehicle ointment topically on the face or balding scalp with AK. | Other | Vehicle ointment |
Primary outcome
Percent Change From Baseline in Lesion Count at Day 57
Time frame: Baseline, Day 57
Percent change from baseline in the AK lesion count at Day 57 was reported.
7 secondary outcomes
Percentage of Participants With Partial Clearance at Day 57
Time frame: At Day 57
Percentage of Participants With Complete Clearance at Day 57
Time frame: At Day 57
Percentage of Participants With Partial Clearance at Day 113
Time frame: At Day 113
Percentage of Participants With Complete Clearance at Day 113
Time frame: At Day 113
Local Tolerability Signs Composite Score at Specific Timepoints
Time frame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
Maximum Local Tolerability Signs Composite Score in Treatment Course
Time frame: At Week 1 to 8 (Day 57) and Week 8 to 16 (Day 113)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest
Time frame: From Baseline up to Day 113
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirbanibulin in people with Keratosis, Actinic, run by Almirall, S.A. at 35 sites in 5 countries.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 30 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 35 sites in Italy, Spain, Germany, Poland, Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Lesion Count at Day 57 (time frame: Baseline, Day 57). 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 30 Jun 2026.