The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
447
Participants will apply tirbanibulin 10 mg/g ointment topically for 5 days over 25 cm\^2 of the face or scalp with Actinic Keratosis (AK).
Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.
Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)
Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
Time frame: Up to 3 years
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An AE does not necessarily have a causal relationship with the medicinal product.
Time frame: Up to 3 years
Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Time frame: Up to 3 years
Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF
Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.
Time frame: Up to 3 years
Time to Occurrence of Invasive SCC From Baseline in the TF
Time to occurrence of invasive SCC from baseline in the TF will be reported.
Time frame: Up to 3 years
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Almirall Investigation Site 102
Lille, France
Almirall Investigation Site 103
Marseille, France
Almirall Investigation Site 104
Nice, France
Almirall Investigational Site 106
Paris, France
Almirall Investigational Site 105
Rouen, France
Almirall Investigational Site 101
Saint-Priest-en-Jarez, France
Almirall Investigational Site 205
Augsburg, Germany
Almirall Investigational Site 211
Bad Bentheim, Germany
Almirall Investigation Site 201
Bochum, Germany
Almirall Investigational Site 214
Bochum, Germany
...and 39 more locations
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
Time frame: Up to 3 years
Percentage of Participants Requiring Rescue Treatment at Any Time During the Study
Percentage of participants requiring rescue treatment at any time during the study will be reported.
Time frame: Up to 3 years
Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks
Percentage of participants with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks will be reported.
Time frame: Up to Week 52
Number of Participants With Vital Signs Abnormalities
Number of participants with vital signs (including measurement of heart rate, respiratory rate, systolic and diastolic blood pressure and tympanic temperature) will be reported.
Time frame: Up to 3 years
Number of Participants With Physical Examination Abnormalities
Number of participants with physical examination abnormalities (height, weight and an assessment of head, eyes, ears, nose and throat, integumentary/dermatological, gastrointestinal, cardiovascular, respiratory, musculoskeletal, and neurological systems) will be reported.
Time frame: Up to 3 years