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

Part of paid clinical trials in New York, New York.

Sponsor
Bruce Robinson, MD
Study ID
NCT07010692
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 16, 2025
Status verified
Sep 2025
Primary completion
May 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Bruce Robinson, MDNew YorkNew York10022
Gillian Nanni, Research Coordinator
[email protected]
212-750-7121
Lexi Research Assistant
[email protected]
212-750-7121
Bruce Robinson, MD (PRINCIPAL_INVESTIGATOR)

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By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Bruce Robinson, MD· New York, NY

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