A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm2 and up to 100 cm2 in Adult Patients With Actinic Keratosis
- Conditions
- Actinic Keratosis on the Face or ScalpMedDRA version: 20.0Level: PTClassification code: 10000614Term: Actinic keratosis Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-505487-11-00
- Lead Sponsor
- Almirall S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 270
Patients with AK who are =18 years old, Having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that: a) contains =4 to =12 clinically typical, visible, and discrete (non-confluent) AK lesions and b) measures more than 25 cm2 (eg, one cheek) and up to approximately 100 cm2 (eg, mid face), Willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study, Women of childbearing potential (WOCBP), ie, 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) must: •have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, •be using highly effective methods of birth control (defined in Appendix 1) for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, •agree to have pregnancy tests while in the study and at the end of the study (according to the Schedule of Assessments in Table 1), and •agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product., Sexually active males with female partners who are WOCBP must agree to use two forms of contraception, one of which must be barrier contraception, from Screening through 90 days after their last dose of study treatment. All non-sterile male patients must agree not to donate sperm or attempt conception from Screening through 90 days following their last dose of study treatment., Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines.
Presence in the TF of: a)Clinically atypical and/or rapidly changing AK lesions in the TF b)Hyperkeratotic or hypertrophic lesions, recalcitrant disease (defined as failure to respond to cryosurgery on 2 previous occasions) and/or cutaneous horn c)History of invasive SCC, Bowen’s disease, basal cell carcinoma (BCC), or other malignant tumours in the TF d)Any other dermatological disease that causes difficulty with examination, Significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the patient to unacceptable risk by study participation, Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing in the current study, Subject is vulnerable as defined in the ICH E6[R2] Guideline for GCP, as a subject whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. For example, a patient who is employee or a relative to an employee at the research site or the Sponsor., Location of the TF is: •On any location other than the face or balding scalp •Within 5 cm of an incompletely healed wound •Within 5 cm of a suspected BCC or other neoplasms •Periorbital, lips, or nostrils, Having a previous treatment with tirbanibulin 10 mg/g ointment, Females who are pregnant or nursing or seeking to become pregnant, Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication or therapy, Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 113, A history of sensitivity and/or allergy to any of the ingredients in the study medication, Patients with significant abnormalities on the medical history, physical examination (PE) findings, vital signs, clinical chemistry, or haematology results that in the judgment of the Investigator may interfere with the interpretation of the results., A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method