A Phase 4 interventional study of Tirbanibulin (Klisyri®) 10 mg/g ointment and Diclofenac Sodium 3% Gel in Keratosis, Actinic, sponsored by Almirall, S.A.. Active, not recruiting at 49 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Almirall, S.A. · Phase 4, Interventional, and Treatment
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 447 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Almirall, S.A. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Tirbanibulin (Klisyri®) 10 mg/g ointment
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.
Drug: Diclofenac Sodium 3% Gel
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).
Also known as: Klisyri®
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
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
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Almirall, S.A.