Keratinocyte CarcinomaPhase 1/2NCT07010692
Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment
A Phase 1/2 study testing Tirbanibulin ointment 1% and non-ablative fractional laser in people with Keratinocyte Carcinoma and Basal Cell Carcinomas, run by Bruce Robinson, MD at 1 site in United States.
Trial summary
The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratinocyte Carcinoma, Basal Cell Carcinomas, Squamous Cell Carcinoma
- What is being tested?
- Tirbanibulin ointment 1% and non-ablative fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to Jun 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cannot be pregnant at the time of treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bruce Robinson, MD
New York, New York, 10022
Gillian Nanni, Research Coordinator, 212-750-7121, info@brucerobinsonmd.com
Lexi Research Assistant, 212-750-7121, info@brucerobinsonmd.com
About this study
Official title: Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.
- Being tested
- Tirbanibulin ointment 1%, non-ablative fractional laser
- Keywords
- Basal Cell Carcinoma, Squamous Cell Carcinoma, BCC, SCC, keratinocyte carcinoma, skin cancer, laser treatment
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirbanibulin ointment 1%Drug
Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.
non-ablative fractional laserDevice
Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Laser Only | Active comparator | Treatment of superficial or in situ carcinomas will be with fractional laser only. Receives: Device: non-ablative fractional laser |
| Fractional Laser and Tirbanibulin Ointment | Active comparator | Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment. Receives: Drug: Tirbanibulin ointment 1%; Device: non-ablative fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.
Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.
Measured: From enrollment to the end of follow-up monitoring at 5 years.
Secondary outcomes (1)
Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)
Review the overall success of the treatment (recurrence and failure rates, appearance, patient satisfaction) compared to traditionally accepted alternative treatments including surgical excision, Mohs surgery, and Electrodesiccation and curettage
Measured: Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 May 2025
- Primary completionMay 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratinocyte CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruce Robinson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Robinson, MD, Principal investigator, Bruce Robinson, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010692
- Sponsor's protocol ID
- 25-06-003-2015
- Status last verified
- Sep 2025
- First submitted
- 30 May 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Robinson BP, Nanni GM. Utilizing fractional lasers and tirbanibulin ointment to treat squamous and basal cell carcinomas. Arch Dermatol Res. 2024 Oct 14;316(10):683. doi: 10.1007/s00403-024-03423-0.
PubMed 39400600
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
- ClinicalTrials.gov ID
- NCT07010692
- Acronym / sponsor ID
- 25-06-003-2015
- Keywords
- Basal Cell Carcinoma, Squamous Cell Carcinoma, BCC, SCC, keratinocyte carcinoma, skin cancer, laser treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bruce Robinson, MDUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 Jun 2025 (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 investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Laser Only | Active comparator | Device: non-ablative fractional laserTreatment of superficial or in situ carcinomas will be with fractional laser only. |
| Fractional Laser and Tirbanibulin Ointment | Active comparator | Drug: Tirbanibulin ointment 1%, Device: non-ablative fractional laserTreatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Cannot be pregnant at the time of treatment
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 |
|---|---|---|
| Tirbanibulin ointment 1%Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas. | Drug | Fractional Laser and Tirbanibulin Ointment |
| non-ablative fractional laserEvery skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser. | Device | Fractional Laser Only, Fractional Laser and Tirbanibulin Ointment |
Primary outcome
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.
Time frame: From enrollment to the end of follow-up monitoring at 5 years.
Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.
1 secondary outcome
Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)
Time frame: Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Results publication: PubMed 39400600Robinson BP, Nanni GM. Utilizing fractional lasers and tirbanibulin ointment to treat squamous and basal cell carcinomas. Arch Dermatol Res. 2024 Oct 14;316(10):683. doi: 10.1007/s00403-024-03423-0.
- Related InfoLink provided by the sponsor.
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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.
Bruce Robinson, MD principal investigator
Bruce Robinson, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tirbanibulin ointment 1% and non-ablative fractional laser in people with Keratinocyte Carcinoma and Basal Cell Carcinomas, run by Bruce Robinson, MD at 1 site in United States.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gillian Nanni, Research Coordinator, BS (212-750-7121, info@brucerobinsonmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years. (time frame: From enrollment to the end of follow-up monitoring at 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07010692, which also lists 1 linked publication.
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 17 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.