Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis (NCT06319794) | Clinical Trial Compass
CompletedPhase 2
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
Switzerland46 participantsStarted 2024-04-02
Plain-language 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
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 rena…
What they're measuring
1
Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
Timeframe: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)