Basal Cell Carcinomas, Keratinocyte Carcinoma, Skin Cancer, Squamous Cell Carcinoma
Conditions
Keywords
Basal Cell Carcinoma, Squamous Cell Carcinoma, BCC, SCC, keratinocyte carcinoma, skin cancer, laser treatment
Brief summary
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
Tirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.
Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
Sponsors
Bruce Robinson, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years. | From enrollment to the end of follow-up monitoring at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, 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. | 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 |
Countries
United States
Contacts
Primary ContactGillian Nanni, Research Coordinator, BS
Outcome results
None listed