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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks
University Hospital Basel / Department of Dermatology
Basel, Switzerland
CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology
Lausanne, Switzerland
Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
Improvement from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale where 0 is complete clearance and 4 is no improvement)
Time frame: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)
Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms)
Proportion of participants with partial (75% reduction in lesions) or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arm)
Time frame: Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)
Incidence of Treatment-Emergent Adverse Events
Safety endpoint assessed by treatment-emergent adverse events (including laboratory adverse events and vital signs)
Time frame: From first application of bimiralisib until 28 days after the last application
Incidence of local skin reactions
Tolerability endpoint assessed by Investigator for specific local skin reactions using 4-point clinical scales for irritation, stinging/burning and pruritus. Scales from 0 (no signs) to 3 (severe)
Time frame: From first application of bimiralisib until 28 days after the last application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.