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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional Laser Only | Active Comparator | Treatment of superficial or in situ carcinomas will be with fractional laser only. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirbanibulin ointment 1% | Drug | Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage) | Review the overall success of the treatment (recurrence and failure rates, appearance, patient satisfaction) compared to traditionally accepted alternative treatments including surgical excision, Mohs surgery, and 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. |
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Inclusion Criteria: biopsy confirmed squamous and/or basal cell carcinoma not previously treated by another method.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gillian Nanni, Research Coordinator, BS | Contact | 212-750-7121 | info@brucerobinsonmd.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruce Robinson, MD | Bruce Robinson, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruce Robinson, MD | Recruiting | New York | New York | 10022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39400600 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2025 | May 27, 2025 |
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| non-ablative fractional laser | Device | Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser. |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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