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 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
Percent change from baseline in the AK lesion count at Day 57 was reported.
Time frame: Baseline, Day 57
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
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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
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.
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
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.
Time frame: From Baseline up to Day 113