Recruiting
Phase 1
Phase 2

Fractional Laser & Tirbanibulin

Sponsor:

Bruce Robinson, MD

Code:

NCT07010692

Conditions

Keratinocyte Carcinoma

Basal Cell Carcinomas

Squamous Cell Carcinoma

Skin Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirbanibulin ointment 1%

non-ablative fractional laser

Study Details

Brief 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.

Conditions

Keratinocyte Carcinoma

Basal Cell Carcinomas

Squamous Cell Carcinoma

Skin Cancer

Study ID

NCT07010692

Start date

May 16, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Fractional Laser Only

Treatment of superficial or in situ carcinomas will be with fractional laser only.

active comparator: Fractional Laser and Tirbanibulin Ointment

Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.

Interventions

Tirbanibulin ointment 1%

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

non-ablative fractional laser

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

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. ]

Central Contacts and Locations

Central contacts

Gillian Nanni, Research Coordinator, BS

212-750-7121info@brucerobinsonmd.com

Locations

Bruce Robinson, MD

Recruiting

New York, New York, United States, 10022

Contacts

Gillian Nanni, Research Coordinator

212-750-7121info@brucerobinsonmd.com

Lexi Research Assistant

212-750-7121info@brucerobinsonmd.com

Principal Investigator:

Bruce Robinson, MD

More Information

Sponsor

Bruce Robinson, MD

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • BCC
  • SCC
  • keratinocyte carcinoma
  • skin cancer
  • laser treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bruce Robinson, MD on 2025-09-17.