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 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.
Participants will apply vehicle ointment topically on the face or balding scalp with AK.
Site 17
Augsburg, Germany
Percent Change From Baseline in Lesion Count at Day 57
Percentage change from baseline in the AK lesion count will be assessed.
Time frame: Baseline, Day 57
Proportion of Participants With Partial Clearance (PC) at Day 57
PC is defined as proportion of participants achieving more than or equal to (\>=) 75 percent (%) clearance of AK lesions in the TF on the face or scalp at Day 57.
Time frame: At Day 57
Proportion of Participants With Complete Clearance (CC) at Day 57
CC is defined as proportion of participants achieving 100 percent clearance of AK lesions in the TF on the face or scalp at Day 57.
Time frame: At Day 57
Proportion of Participants With Partial Clearance (PC) by Day 113
Time frame: Baseline up to Day 113
Proportion of Participants With Complete Clearance (CC) by Day 113
Time frame: Baseline up to Day 113
Local Tolerability Signs Composite Score at Specific Timepoints
Local tolerability signs composite score (0-18) at Specific Timepoints, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms.
Time frame: 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 (0-18) in treatment course, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms.
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Site 1
Bad Bentheim, Germany
Site 3
Bochum, Germany
Site 18
Dresden, Germany
Site 2
Hamburg, Germany
Site 5
Hamburg, Germany
Site 4
Mahlow, Germany
Site 6
Wuppertal, Germany
Site 24
Bari, Italy
Site 25
Bologna, Italy
...and 25 more locations
Time frame: At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113
Number of Participants With Adverse Event (AE), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
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. 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; is 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.
Time frame: From Screening up to Day 113