Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (NCT NCT06135415)

NCT ID: NCT06135415

Last Updated: 2026-06-30

Results Overview

Percent change from baseline in the AK lesion count at Day 57 was reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

280 participants

Primary outcome timeframe

Baseline, Day 57

Results posted on

2026-06-30

Participant Flow

At total of 280 participants were enrolled in this study. Results in this summary are reported based on the primary completion date of the study (April 30, 2025). Additional information related to follow-up period will be reported during Study completion date.

Participant milestones

Participant milestones
Measure	Vehicle Ointment Participants applied vehicle ointment topically to the Treatment field (TF) located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g Participants applied tirbanibulin 10 milligrams per gram (mg/g) ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Overall Study STARTED	93	187
Overall Study Safety Population	93	186
Overall Study COMPLETED	74	165
Overall Study NOT COMPLETED	19	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Ointment Participants applied vehicle ointment topically to the Treatment field (TF) located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g Participants applied tirbanibulin 10 milligrams per gram (mg/g) ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Overall Study Adverse Event	1	0
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	0	3
Overall Study Protocol Deviation	0	1
Overall Study Withdrawal by Subject	18	16

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=187 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Total n=280 Participants Total of all reporting groups
Age, Continuous	73.1 years STANDARD_DEVIATION 9.34 • n=20 Participants	73.5 years STANDARD_DEVIATION 9.01 • n=20 Participants	73.4 years STANDARD_DEVIATION 9.11 • n=40 Participants
Sex: Female, Male Female	17 Participants n=20 Participants	28 Participants n=20 Participants	45 Participants n=40 Participants
Sex: Female, Male Male	76 Participants n=20 Participants	159 Participants n=20 Participants	235 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=20 Participants	13 Participants n=20 Participants	23 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=20 Participants	166 Participants n=20 Participants	248 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	8 Participants n=20 Participants	9 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	68 Participants n=20 Participants	136 Participants n=20 Participants	204 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=20 Participants	51 Participants n=20 Participants	76 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline, Day 57

Population: ITT population included all randomized participants. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure

Percent change from baseline in the AK lesion count at Day 57 was reported.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=82 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=178 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Percent Change From Baseline in Lesion Count at Day 57	-25.23 Percent change Standard Error 3.96	-64.15 Percent change Standard Error 2.87

SECONDARY outcome

Timeframe: At Day 57

Population: ITT population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=187 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Percentage of Participants With Partial Clearance at Day 57	20.4 Percentage of participants Interval 13.49 to 29.72	58.8 Percentage of participants Interval 51.66 to 65.63

SECONDARY outcome

Timeframe: At Day 57

Population: ITT population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=187 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Percentage of Participants With Complete Clearance at Day 57	15.1 Percentage of participants Interval 9.18 to 23.7	41.2 Percentage of participants Interval 34.37 to 48.34

SECONDARY outcome

Timeframe: At Day 113

Population: ITT population included all randomized participants.

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

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=187 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Percentage of Participants With Partial Clearance at Day 113	25.8 Percentage of participants Interval 18.0 to 35.53	65.2 Percentage of participants Interval 58.17 to 71.7

SECONDARY outcome

Timeframe: At Day 113

Population: ITT population included all randomized participants.

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

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=187 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Percentage of Participants With Complete Clearance at Day 113	23.7 Percentage of participants Interval 16.17 to 33.23	56.1 Percentage of participants Interval 48.98 to 63.07

SECONDARY outcome

Timeframe: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113

Population: Safey population. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies who were evaluable at specific timepoints. Participants who achieved complete clearance at Day 57 were not scheduled to attend Days 64, 71, and 85, as no second treatment course was indicated per protocol. Consequently, no assessments were performed, and no data were collected at those 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.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=92 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=185 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Local Tolerability Signs Composite Score at Specific Timepoints Baseline (Day 1)	0.8 Score on a scale Standard Deviation 1.68	0.9 Score on a scale Standard Deviation 1.64
Local Tolerability Signs Composite Score at Specific Timepoints At Day 8	1.0 Score on a scale Standard Deviation 1.47	4.0 Score on a scale Standard Deviation 2.72
Local Tolerability Signs Composite Score at Specific Timepoints At Day 15	0.7 Score on a scale Standard Deviation 1.26	1.8 Score on a scale Standard Deviation 1.72
Local Tolerability Signs Composite Score at Specific Timepoints At Day 29	0.6 Score on a scale Standard Deviation 1.23	0.6 Score on a scale Standard Deviation 0.99
Local Tolerability Signs Composite Score at Specific Timepoints At Day 57	0.5 Score on a scale Standard Deviation 1.21	0.4 Score on a scale Standard Deviation 0.84
Local Tolerability Signs Composite Score at Specific Timepoints At Day 113	0.3 Score on a scale Standard Deviation 0.84	0.2 Score on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: At Week 1 to 8 (Day 57) and Week 8 to 16 (Day 113)

Population: Safey population included all randomized participants who received at least 1 application of study treatment during the Core Study and was used for all safety analyses in the Core Study. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies who were evaluable at specific timepoints.

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.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=186 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Maximum Local Tolerability Signs Composite Score in Treatment Course At Week 1 to 8	1.3 Score on a scale Standard Deviation 1.80	4.1 Score on a scale Standard Deviation 2.68
Maximum Local Tolerability Signs Composite Score in Treatment Course At Week 8 to 16	0.7 Score on a scale Standard Deviation 0.93	2.9 Score on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: From Baseline up to Day 113

Population: Safey population included all randomized participants who received at least 1 application of study treatment during the Core Study and was used for all safety analyses in the Core Study.

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.

Outcome measures

Outcome measures
Measure	Vehicle Ointment n=93 Participants Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=186 Participants Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest TEAEs	28 Participants	79 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest Serious TEAEs	2 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAE of Special Interest TEAE of Special Interest	2 Participants	2 Participants

Adverse Events

Vehicle Ointment

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Tirbanibulin 10 mg/g

Serious events: 9 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle Ointment n=93 participants at risk Participants applied vehicle ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.	Tirbanibulin 10 mg/g n=186 participants at risk Participants applied tirbanibulin 10 mg/g ointment topically to the TF located in the face or balding scalp, once daily for 5 days starting on Day 1.
Gastrointestinal disorders Melaena	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Gastrointestinal disorders Peritoneal adhesions	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
General disorders Multiple organ dysfunction syndrome	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Infections and infestations Pneumonia	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	1.1% 2/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.1% 1/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.00% 0/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Renal and urinary disorders Renal colic	1.1% 1/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.00% 0/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Renal and urinary disorders Renal failure	1.1% 1/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.00% 0/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).
Renal and urinary disorders Urinary retention	0.00% 0/93 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).	0.54% 1/186 • Baseline up to Day 113 Treatment-emergent AEs / SAEs (AEs that occurred after the first administration of the IMP, either tirbanibulin or Vehicle, during the study), up to Day 113 (Week 16).

Other adverse events

Additional Information

Begoña Duarte / Global Clinical Operations manager

Almirall S.A

Phone: +34932913636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place