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

Bruce Robinson, MD

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Squamous Cell Carcinoma; Skin Cancer; Basal Cell Carcinomas; Keratinocyte Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07010692

25-06-003-2015

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Fractional Laser Only

Active Comparator group

Description:

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

Treatment:

Device: non-ablative fractional laser

Fractional Laser and Tirbanibulin Ointment

Active Comparator group

Description:

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

Treatment:

Device: non-ablative fractional laser

Drug: Tirbanibulin ointment 1%