A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Keratosis, Actinic
About this trial
This is an interventional treatment trial for Keratosis, Actinic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Almirall Investigation Site 102
- Almirall Investigation Site 103
- Almirall Investigation Site 104
- Almirall Investigational Site 106
- Almirall Investigational Site 101
- Almirall Investigational Site 205
- Almirall Investigation Site 201
- Almirall Investigational Site 208
- Almirall Investigational Site 210
- Almirall Investigational Site 204
- Almirall Investigational Site 206
- Almirall Investigational Site 207
- Almirall Investigational Site 209
- Almirall Investigation Site 202
- Almirall Investigational Site 309
- Almirall Investigational Site 302
- Almirall Investigational Site 304
- Almirall Investigational Site 308
- Almirall Investigational Site 301
- Almirall Investigational Site 303
- Almirall Investigational Site 305
- Almirall Investigational Site 306
- Almirall Investigational Site 307
- Almirall Investigational Site 310
- Almirall Investigational Site 27
- Almirall Investigational Site 403
- Almirall Investigational Site 26
- Almirall Investigational Site 408
- Almirall Investigational Site 407
- Almirall Investigational Site 401
- Almirall Investigational Site 402
- Almirall Investigational Site 502
- Almirall Investigational Site 508
- Almirall Investigational Site 507
- Almirall Investigational Site 509
- Almirall Investigational Site 503Recruiting
- Almirall Investigational Site 504
- Almirall Investigational Site 505
- Almirall Investigational Site 506
- Almirall Investigational Site 501
- Almirall Investigational Site 709
- Almirall Investigational Site 703
- Almirall Investigational Site 708
- Almirall Investigational Site 704
- Almirall Investigational Site 701
- Almirall Investigational Site 706
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tirbanibulin 10 milligram per gram (mg/g) ointment
Diclofenac Sodium 3% Gel
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.
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.