Fractional laser plus tirbanibulin ointment for basal and squamous cell skin cancers
Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
PHASE1; PHASE2 · Bruce Robinson, MD · NCT07010692
This trial will try combining fractional laser treatment with tirbanibulin ointment to see if it can treat biopsy-confirmed basal cell and squamous cell skin cancers and reduce the need for surgery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bruce Robinson, MD (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07010692 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial uses non-ablative fractional lasers (thulium and erbium) and adjunct bulk heating methods on biopsy-confirmed basal cell carcinomas (BCC) and squamous cell carcinomas (SCC). After laser and heating treatment, subjects may apply tirbanibulin 1% ointment over five nights depending on lesion invasiveness. The approach aims to enhance topical drug delivery and achieve tumor clearance without standard surgical excision. Outcomes will include treatment response and safety, with attention to cosmetic results.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-confirmed basal or squamous cell carcinoma that has not been previously treated and who can attend in-person visits at the study site.
Not a fit: Patients with deeply invasive tumors, metastatic disease, lesions previously treated by other methods, or those who cannot undergo the laser procedure (including pregnant individuals) may not benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could reduce the need for invasive surgery and improve cosmetic outcomes for patients with superficial BCC or SCC.
How similar studies have performed: Topical tirbanibulin is approved for actinic keratoses and laser-assisted topical therapies have been explored for superficial skin cancers, but combining fractional laser with tirbanibulin for BCC/SCC is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: biopsy confirmed squamous and/or basal cell carcinoma not previously treated by another method. Exclusion Criteria: * Cannot be pregnant at the time of treatment
Where this trial is running
New York, New York
- Bruce Robinson, MD — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Bruce Robinson, MD — Bruce Robinson, MD
- Study coordinator: Gillian Nanni, Research Coordinator, BS
- Email: info@brucerobinsonmd.com
- Phone: 212-750-7121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratinocyte Carcinoma, Basal Cell Carcinomas, Squamous Cell Carcinoma, Skin Cancer, Basal Cell Carcinoma, BCC, SCC, keratinocyte carcinoma