study on the safety and efficacy of bimiralisib gel in participants suffering from actinic keratosis

Conditions: Actinic Keratosis

Summary: the aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (ak) on the face and/or scalp and/or back of hands

this is a multi-center, randomized, open label, parallel group study. the study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment. the study consists of the following periods: * screening (up to 30 days) * treatment (2 or 4 weeks) * follow-up (4 weeks) participants will be randomized to one of two groups (1:1): * arm a: topical bimiralisib gel treatment for 2 weeks * arm b: topical bimiralisib gel treatment for 4 weeks

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