Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06319794
Eligibility Criteria:
Key Inclusion Criteria:
* Must be of at least 50 years of age, at the time of signing the informed consent.
* Have a clinical diagnosis of stable, clinically typical actinic keratosis.
* Have at least 3 actinic keratosis lesions contained within contiguous treatment regions of face and/or scalp and/or back of hands.
* Must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.
* Must be willing to comply with sun avoidance measures for all exposed areas including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.
* Must be in good general health (ECOG 0-1)
* Participants of reproductive potential must agree to use double effective contraception from screening until 90 days after discontinuing study treatment.
* Female participants who had a menstrual cycle within 2 years prior to screening must have a negative serum pregnancy test at screening and a negative urine pregnancy test on their first treatment day.
* Must be capable of giving signed informed consent
Key Exclusion Criteria:
* Known or suspected hypersensitivity to any of the excipients of bimiralisib gel.
* Clinically atypical and/or rapidly changing actinic keratosis lesions in the treatment area.
* Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
* Participation in any clinical research study within 30 days of the Baseline Visit.
* Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy, cryotherapy) within 4 weeks of the Baseline visit and within 2 cm of the selected treatment area.
* Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to the Baseline Visit or planned use during the study.
* Use of any retinoids within 90 days of the Baseline Visit, or glucocorticosteroids, methotrexate or other anti-metabolites or nicotinamide within 28 days of the Baseline Visit.
* Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.
* Any other malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not in the treatment area that were treated with curative intent and are without recurrence.
* Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06319794
Study Brief:
Protocol Section:
NCT06319794