Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment

September 15, 2025 updated by: Bruce Robinson, MD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10022
        • Recruiting
        • Bruce Robinson, MD
        • Contact:
        • Principal Investigator:
          • Bruce Robinson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fractional Laser Only
Treatment of superficial or in situ carcinomas will be with fractional laser only.
Device: non-ablative fractional laser
Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
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.
Device: non-ablative fractional laser
Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
Drug: Tirbanibulin ointment 1%
Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow-up monitoring at 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruce Robinson, MD

Investigators

  • Principal Investigator: Bruce Robinson, MD, Bruce Robinson, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

May 30, 2025

First Submitted That Met QC Criteria

May 30, 2025

First Posted (Actual)

June 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-06-003-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Cancer

Clinical Trials on non-ablative fractional laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe