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RecruitingInterventionalPhase 1/Phase 2

Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas

NCT ID: NCT07010692Sponsor: Bruce Robinson, MDLast updated: 2025-09-17

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. 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.

Arms & interventions

  • DrugTirbanibulin ointment 1%

    Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.

  • Devicenon-ablative fractional laser

    Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.

Outcome measures

Primary

  • 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.

    Time frame: From enrollment to the end of follow-up monitoring at 5 years.

Secondary

  • 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.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Bruce Robinson, MD

New York, New York, 10022

Recruiting
Gillian Nanni, Research Coordinator · Contact
Lexi Research Assistant · Contact
Bruce Robinson, MD · Principal Investigator

References

  • 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)
Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment | Cancerify