Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

Launched by TORQUR · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called bimiralisib gel for people with actinic keratosis (AK), which are rough, scaly patches on the skin often caused by sun damage. The trial aims to find out how safe and effective this gel is for treating AK on areas like the face, scalp, and back of the hands. The trial is currently recruiting participants who are at least 50 years old and have at least three AK lesions in the treatment areas. It's important for participants to agree to certain guidelines, such as not using other products on the treatment area and avoiding direct sunlight.

Eligible participants must be in good general health and be willing to follow specific sun protection measures during the study. They should also be able to provide informed consent, which means they understand the trial and agree to take part. Throughout the study, participants will be closely monitored for any side effects and to see how well the treatment is working. If you or someone you know has actinic keratosis and fits these criteria, this trial could be an opportunity to access a new potential treatment while contributing to important research.

Gender

ALL

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