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1. Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF) (Time Frame - Up to 3 years): Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
Secondary outcome:
1. Number of Participants With Adverse Events (AEs) (Time Frame - Up to 3 years): 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.
2. Number of Participants With Serious Adverse Events (SAEs) (Time Frame - Up to 3 years): 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).
3. Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF (Time Frame - Up to 3 years): Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.
4. Time to Occurrence of Invasive SCC From Baseline in the TF (Time Frame - Up to 3 years): Time to occurrence of invasive SCC from baseline in the TF will be reported.
5. Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course (Time Frame - Up to 3 years): Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
6. Percentage of Participants Requiring Rescue Treatment at Any Time During the Study (Time Frame - Up to 3 years): Percentage of participants requiring rescue treatment at any time during the study will be reported.
7. Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks (Time Frame - Up to Week 52): Percentage of participants with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks will be reported.
8. Number of Participants With Vital Signs Abnormalities (Time Frame - Up to 3 years): Number of participants with vital signs (including measurement of heart rate, respiratory rate, systolic and diastolic blood pressure and tympanic temperature) will be reported.
9. Number of Participants With Physical Examination Abnormalities (Time Frame - Up to 3 years): 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.
Experimental: Tirbanibulin 10 milligram per gram (mg/g) ointment Participants will apply tirbanibulin ointment 10 mg/g once daily to the treatment field (TF) for 5 consecutive days beginning Day 1. At subsequent visits, participants will have the option of an additional 5-day course(s) (with at least 16 weeks between starting date of treatment courses) at the discretion of the investigator if actinic keratosis (AK) lesions are present in the TF and physical treatment is not appropriate.
Active Comparator: Diclofenac Sodium 3% Gel Participants will apply diclofenac sodium 3% gel twice daily to the TF for 60 to 90 days beginning Day 1, with the option of further courses every 6 months (with at least 6 months between starting date of treatment courses) if lesions are found to be present in the TF at follow up visits and physical treatment is not appropriate.
Tirbanibulin (Klisyri®) 10 mg/g ointment (Klisyri®): 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).
Diclofenac Sodium 3% Gel: Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp"
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