A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
- Conditions
- Keratosis, Actinic
- Interventions
- Registration Number
- NCT05387525
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 447
- A treatment field (TF) on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: a) is a contiguous area measuring 25 cm^2, b) contains 2 to 8 clinically typical, visible, and discrete actinic keratosis (AK) lesions, and c) has an overall clinical picture that is consistent with Olsen grade 1
- If a women of child-bearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must: a) Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration. b) Be using effective methods of birth control. c) Agree to have pregnancy tests while in the study and at the end of the study
- Participants should be willing to avoid sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
- Participants should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
- The location of the TF is: a) on any location other than the face or scalp. b) within 5 centimeters (cm) of an incompletely healed wound. c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm. d) on the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils
- Presence in the TF of: a) clinically atypical and/or rapidly changing AK lesions b) hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) confluent AK lesions (that is, non-discrete lesions, as per inclusion criterion 2). d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3 percent (%) gel
- History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely
- History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study
- Immunocompromised participants, including participants with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac Sodium 3% Gel 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 10 milligram per gram (mg/g) ointment Tirbanibulin (Klisyri®) 10 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF) Up to 3 years Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF Up to 3 years Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.
Time to Occurrence of Invasive SCC From Baseline in the TF Up to 3 years Time to occurrence of invasive SCC from baseline in the TF will be reported.
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course Up to 3 years Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks 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.
Number of Participants With Vital Signs Abnormalities 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.
Number of Participants With Physical Examination Abnormalities 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.
Number of Participants With Adverse Events (AEs) 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.
Number of Participants With Serious Adverse Events (SAEs) 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).
Percentage of Participants Requiring Rescue Treatment at Any Time During the Study Up to 3 years Percentage of participants requiring rescue treatment at any time during the study will be reported.
Trial Locations
- Locations (49)
Almirall Investigational Site 207
🇩🇪Marburg, Germany
Almirall Investigational Site 302
🇮🇹Brescia, Italy
Almirall Investigational Site 401
🇵🇱Wrocław, Poland
Almirall Investigational Site 508
🇪🇸Barcelona, Spain
Almirall Investigational Site 507
🇪🇸Granada, Spain
Almirall Investigational Site 501
🇪🇸Zaragoza, Spain
Almirall Investigational Site 708
🇬🇧Oxford, United Kingdom
Almirall Investigational Site 304
🇮🇹Genova, Italy
Almirall Investigational Site 310
🇮🇹Rozzano, Italy
Almirall Investigational Site 402
🇵🇱Wrocław, Poland
Almirall Investigational Site 502
🇪🇸Barcelona, Spain
Almirall Investigational Site 509
🇪🇸Granada, Spain
Almirall Investigational Site 503
🇪🇸Madrid, Spain
Almirall Investigation Site 102
🇫🇷Lille, France
Almirall Investigational Site 307
🇮🇹Roma, Italy
Almirall Investigational Site 403
🇵🇱Lublin, Poland
Almirall Investigational Site 407
🇵🇱Warsaw, Poland
Almirall Investigational Site 101
🇫🇷Saint-Priest-en-Jarez, France
Almirall Investigational Site 206
🇩🇪Hamburg, Germany
Almirall Investigational Site 211
🇩🇪Bad Bentheim, Germany
Almirall Investigational Site 212
🇩🇪Bonn, Germany
Almirall Investigational Site 204
🇩🇪Erlangen, Germany
Almirall Investigational Site 301
🇮🇹Napoli, Italy
Almirall Investigational Site 309
🇮🇹Arezzo, Italy
Almirall Investigational Site 214
🇩🇪Bochum, Germany
Almirall Investigation Site 103
🇫🇷Marseille, France
Almirall Investigational Site 510
🇪🇸Barcelona, Spain
Almirall Investigation Site 104
🇫🇷Nice, France
Almirall Investigational Site 105
🇫🇷Rouen, France
Almirall Investigational Site 208
🇩🇪Detmold, Germany
Almirall Investigational Site 210
🇩🇪Dresden, Germany
Almirall Investigational Site 305
🇮🇹Roma, Italy
Almirall Investigational Site 209
🇩🇪Merzig, Germany
Almirall Investigational Site 308
🇮🇹Modena, Italy
Almirall Investigation Site 202
🇩🇪Recklinghausen, Germany
Almirall Investigational Site 213
🇩🇪Hamburg, Germany
Almirall Investigational Site 406
🇵🇱Rzeszów, Poland
Almirall Investigational Site 106
🇫🇷Paris, France
Almirall Investigational Site 205
🇩🇪Augsburg, Germany
Almirall Investigation Site 201
🇩🇪Bochum, Germany
Almirall Investigational Site 704
🇬🇧Poole, United Kingdom
Almirall Investigational Site 303
🇮🇹Reggio Emilia, Italy
Almirall Investigational Site 306
🇮🇹Roma, Italy
Almirall Investigational Site 703
🇬🇧London, United Kingdom
Almirall Investigational Site 504
🇪🇸Salamanca, Spain
Almirall Investigational Site 505
🇪🇸Sevilla, Spain
Almirall Investigational Site 506
🇪🇸Valence, Spain
Almirall Investigational Site 709
🇬🇧London, United Kingdom
Almirall Investigational Site 706
🇬🇧Weston-super-Mare, United Kingdom