Actinic KeratosisPhase 2NCT06319794
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
A Phase 2 study testing Bimiralisib in people with Actinic Keratosis, run by TORQUR at 2 sites in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Bimiralisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 2 Apr 2024to 24 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel / Department of Dermatology
Basel
CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology
Lausanne
About this study
Official title: A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period
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
Read the 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
- Conditions
- Actinic Keratosis
- Being tested
- Bimiralisib
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimiralisibDrug
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
BimiralisibDrug
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bimiralisib - 2 weeks treatment | Experimental | Topical bimiralisib for 2 weeks Receives: Drug: Bimiralisib |
| Bimiralisib - 4 weeks treatment | Experimental | Topical bimiralisib for 4 weeks Receives: Drug: Bimiralisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: From first application of bimiralisib until 28 days after the last application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start2 Apr 2024
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- TORQUR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319794
- Sponsor's protocol ID
- TQR-BTOP-101
- Status last verified
- Jun 2025
- First submitted
- 6 Mar 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period
- ClinicalTrials.gov ID
- NCT06319794
- Acronym / sponsor ID
- TQR-BTOP-101
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- TORQURIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimiralisib - 2 weeks treatment | Experimental | Drug: BimiralisibTopical bimiralisib for 2 weeks |
| Bimiralisib - 4 weeks treatment | Experimental | Drug: BimiralisibTopical bimiralisib for 4 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimiralisibParticipants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks | Drug | Bimiralisib - 2 weeks treatment |
| BimiralisibParticipants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks | Drug | Bimiralisib - 4 weeks treatment |
Primary outcome
Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
Time frame: 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)
3 secondary outcomes
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)
Time frame: Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)
Incidence of Treatment-Emergent Adverse Events
Time frame: From first application of bimiralisib until 28 days after the last application
Incidence of local skin reactions
Time frame: From first application of bimiralisib until 28 days after the last application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimiralisib in people with Actinic Keratosis, run by TORQUR at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (time frame: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.