Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirbanibulin ointment 1%, non-ablative fractional laser.
- Who it may be relevant to
- Registry conditions: Keratinocyte Carcinoma, Basal Cell Carcinomas, Squamous Cell Carcinoma, Skin Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
Overview
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.
Interventions
- Drug Tirbanibulin ointment 1%
Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas. - Device non-ablative fractional laser
Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
Primary outcome measures
- 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.]
Secondary outcome measures (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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bruce Robinson, MD — New York
Publications
- 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
Identifiers
NCT: NCT07010692 · 25-06-003-2015