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

NCT ID: NCT07010692

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2030-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Keratinocyte Carcinoma Basal Cell Carcinomas Squamous Cell Carcinoma Skin Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional Laser Only

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

Group Type ACTIVE_COMPARATOR

non-ablative fractional laser

Intervention Type DEVICE

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

Fractional Laser and Tirbanibulin Ointment

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

Group Type ACTIVE_COMPARATOR

Tirbanibulin ointment 1%

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Tirbanibulin ointment 1%

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

Intervention Type DRUG

non-ablative fractional laser

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

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* Cannot be pregnant at the time of treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bruce Robinson, MD

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Bruce Robinson, MD

Locations

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Bruce Robinson, MD

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gillian Nanni, Research Coordinator, BS

Role: CONTACT

212-750-7121

Facility Contacts

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Gillian Nanni, Research Coordinator

Role: primary

212-750-7121

Lexi Research Assistant

Role: backup

212-750-7121

References

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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.

Reference Type RESULT
PMID: 39400600 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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25-06-003-2015

Identifier Type: -

Identifier Source: org_study_id

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