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NCT Number: NCT07010692

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

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.

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Key information

Conditions

Keratinocyte Carcinoma Basal Cell Carcinomas Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 laser

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gillian Nanni, Research Coordinator, BS

CONTACT

[email protected]

212-750-7121

Sponsors and collaborators

Lead sponsor

Bruce Robinson, MD

Other

Registry information

Official study title

Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 8, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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