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

NCT07010692 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 25-06-003-2015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, 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.

Study Arms (2)

Fractional Laser Only

ACTIVE COMPARATOR

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

Device: non-ablative fractional laser

Fractional Laser and Tirbanibulin Ointment

ACTIVE COMPARATOR

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

Drug: Tirbanibulin ointment 1%; Device: non-ablative fractional laser

Interventions

Tirbanibulin ointment 1% DRUG

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

Fractional Laser and Tirbanibulin Ointment

non-ablative fractional laser DEVICE

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

Fractional Laser Only; Fractional Laser and Tirbanibulin Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Cannot be pregnant at the time of treatment

Sponsors & Collaborators

• Bruce Robinson, MD: lead

Study Sites (1)

Bruce Robinson, MD

New York, New York, 10022, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39400600 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Skin Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce Robinson, MD

  Bruce Robinson, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Nanni, Research Coordinator, BS

CONTACT

212-750-7121; info@brucerobinsonmd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)