Actinic Keratosis
Conditions
Brief 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
Detailed description
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
Interventions
DRUGBimiralisib
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
Sponsors
TORQUR
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 | Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Day 15 (Treatment Arm A), Day 29 (Treatment Arm B) | 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) |
| Incidence of Treatment-Emergent Adverse Events | From first application of bimiralisib until 28 days after the last application | Safety endpoint assessed by treatment-emergent adverse events (including laboratory adverse events and vital signs) |
| Incidence of local skin reactions | From first application of bimiralisib until 28 days after the last application | 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) |
Countries
Switzerland
Outcome results
None listed