Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
Phase: PHASE1
Conditions: Keratinocyte Carcinoma, Basal Cell Carcinomas, Squamous Cell Carcinoma, Skin Cancer
Sponsor: Bruce Robinson, MD

Protocol 
Bruce Robinson, MD & Gillian Nanni, BS 
 
 
Preliminary/background data:  
Our prior research and clinical data prior to collaboration with BRANY IRB may be read in the published article int 
the following link: https://link.springer.com/content/pdf/10.1007/s00403-024-03423-0.pdf.  
“Our research presents an innovative approach to treating basal and squamous cell carcinomas through the 
combination of fractional laser therapy and tirbanibulin ointment. Since the treatment of our first participant, we 
have observed 100% clinical and/or histological clearance of lesions in all subjects over one year. The joint action of 
both the thulium and erbium lasers, bulk heating with a heat shock response, and the predicted improved penetration 
of the tirbanibulin ointment demonstrates an effective strategy for the destruction of these cancerous cells. In 
addition, the feld effect of the treatment may decrease the risk of recurrence and adjacent cancers in the future. This 
study holds the potential to positively impact nearly 5 million Americans annually who suffer from basal and 
squamous cell carcinomas. The advantages of laser treatment, including the absence of scarring and bleeding, quick 
healing, and non-invasiveness, address the specific needs of various patient populations. In conclusion, the findings 
of this study ofer a groundbreaking and patient-centric solution for basal and squamous cell carcinoma treatment. 
The possibility to improve the lives of millions paves the way for a paradigm shift in skin cancer management.” 
 
“Fractional laser skin treatment is associated with a relatively low complication rate. Side effects and complications 
observed in this study were temporary and did not result in long-term or significantly severe sequelae (e.g., 
scarring).” Per: Graber EM, Tanzi EL, Alster TS. Side effects and complications of fractional laser 
photothermolysis: experience with 961 treatments. Dermatol Surg. 2008 Mar;34(3):301-5; discussion 305-7. doi: 
10.1111/j.1524-4725.2007.34062.x. Epub 2008 Jan 8. PMID: 18190541. 
 
 
Rationale  
Basal cell carcinomas (BCC) and squamous cell carcinomas (SCC) are the most common forms of cancer in the 
United States. The current most commonly accepted treatments for SCCs and BCCs depending on the location and 
depth, are surgical removal, electrodessication and curettage, or Mohs surgery. Although these treatments were 
created to limit the destruction of surrounding healthy cells, all treatments typically leave a scar. Tirbanibulin 
ointment is one of the leading topical medications for the treatment of actinic keratoses, which can progress into 
SCCs and less commonly into BCCs. Studies have found that non-ablative fractional laser therapy can be an 
effective treatment for actinic keratoses. Researchers have also tested the treatment of keratinocyte carcinomas with 
varying laser types and results. However, in this study we have carefully selected the laser type, settings, and 
treatment design, and have incorporated the use of  tirbanibulin ointment, predicting a field effect response and 
increased depth of penetration. 
 
Study Objective  
We seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and 
basal cell carcinomas. We will execute this 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, instruct subjects 
to apply the ointment over the course of five nights immediately following the treatment. The intention of this study 
 
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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.  
 
Design, Selection Criteria, Data Source  
Study design: Longitudinal, forward directed, interventional 
Study type: prospective  
Methodology: site-based (Bruce Robinson, MD private practice dermatology office)  
Patient population: The dermatology office is located in New York, NY but patients may come from any origin. 
The patient population consists of any patient, new or established, of Dr. Bruce Robinson. Patients must have a 
biopsy confirmed BCC and/or SCC skin cancer confirmed by a dermatopathologist either under the care of Dr. 
Robinson or another physician.  
 
Expected study duration: Approximately 5 years. To ensure the clearance of skin cancer, we will track our patients 
for at least 5 years. All patients with a history of skin cancer, including those in this study, are carefully monitored 
and instructed to return for biannual skin exams or earlier if they notice any abnormalities at the site of the 
treatment.  
 
 
 
Schedule of events/visits: 
-Visit #1: In office laser treatment  
 
**For nodular/invasive carcinomas:  
-Night of Visit #1: At home ointment application to treated site 
-Night #2- Night #5: At home ointment application to treated site 
 
-For approximately 10-14 days following competition of ointment application: At home wound care performed 
twice a day at the treated site. Patients instructed to complete wound care until site is completely healed (for some 
could take up to 1 month) 
1 month post-tx: Follow-up to check site (Take biopsy per patient consent) 
6 month post-tx: Follow-up for complete skin exam and to check site  
1 year:  Follow-up for complete skin exam and to check site (Take biopsy per patient consent) 
1.5 year:  Follow-up for complete skin exam and to check site  
2 years:  Follow-up for complete skin exam and to check site  (Take biopsy per patient consent) 
2.5 year: Follow-up for complete skin exam and to check site  
3 year: Follow-up for complete skin exam and to check site  (Take biopsy per patient consent) 
3.5 year: Follow-up for complete skin exam and to check site  
 
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4 year: Follow-up for complete skin exam and to check site  (Take biopsy per patient consent) 
4.5 year: Follow-up for complete skin exam and to check site  
5 year: Follow-up for complete skin exam and to check site (Take biopsy per patient consent) 
**Advise biannual skin exam thereafter (always recommended to any patients with history of SCC/BCC skin 
cancer) 
**Advise return to office ASAP if abnormalities occur at site at any point in time 
 
Patient recruitment: Established patients will be recruited if they develop biopsy confirmed SCC or BCCs. They 
will be given the option to participate in the study. For new patients, recruitment will be based on referrals by current 
patients or other physicians. Additionally, new patients may be recruited through the office website, social media, or 
other online marketing conducted by employees of Dr Bruce Robinson.  
 
Patient retention: Patients will be instructed of the importance of returning to the office for the scheduled follow 
ups. Patients will be closely tracked and monitored. We collect cell, home, mobile, and emergency numbers, emails, 
and addresses from all patients under our care. This provides multiple ways to contact patients. Patients will be 
instructed to make follow up appointments before leaving the office, if they don’t then we will call when they are 
due. Patients are always called, texted, and/or emailed prior to their appointments to confirm. No show patients will 
be contacted multiple times. If no response is given after multiple electronic attempts, then letters are mailed to 
patients. These letters outline the importance of returning to the office for care and the risks associated with not 
returning.  
 
Patient criteria: Participants must have a biopsy confirmed (by a pathologist or dermatopathologist) BCC and/or 
SCC and/or an hypertrophic actinic keratosis (solar keratosis) that extends to the base of a specimen and a BCC or 
SCC cannot be ruled out by the dermatopathologist. The carcinoma can be any level of invasiveness. Patients can be 
of any skin type, demographic, ethnicity or gender.   The carcinoma cannot have been previously treated by any 
other means (surgical excision, laser, Mohs, electrodissection, topical, etc.) Patients must be 18 years or older. 
Patients cannot be pregnant. We do not declare any other exclusion criteria in relation to previous or current 
diagnoses, surgeries, or medications.  
 
Potential bias: 
-selection bias: Patients are recruited from an NYC based dermatology office. Patients must have the means to pay 
for the treatment as it is not covered by insurance (although prices may be discounted or negotiated, and free 
treatment may be offered, on a case to case bases depending on available resources and patient needs) 
-risk of attrition bias if patients do not follow up or drop out of the study  
-reporting bias: part of this study requires patients to complete a 5 night course of ointment application. We are 
trusting that the patient is completing and accurately reporting this in accordance with our detailed instructions 
provided.  
 
IRB APPROVED
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Data source: Collected by Dr. Bruce Robinson or by his medical assistants and inputted into Macpractice electronic 
medical record.  
 
Outcomes of interest: 
primary 
1.​
Successful cure with the experimental method on all participants 
 vs. clinical recurrence or worsening  
secondary 
1.​
The experimental method successfully treats one type of cancer but not the other (BCCs but not SCCs or 
vice versa) 
2.​
The experimental method successfully treats early stages of the cancers, but not later stages (ex. Treats 
superficial SCCs but not invasive SCCs) 
3.​
The experimental method successfully treats only specific parts of the body (ex. Treats areas of the body 
with thinner skin like the face, but not areas of thicker skin like on the back.) 
4.​
The experimental trial method successfully treats only certain patients (differing results depending on age, 
skin type, ethnicity, etc). 
 
Data Collection/Data Management, Quality Control of Data 
-All data will be tracked by Bruce Robinson and his medical assistants 
-Detailed visit information, treatment and follow-up notes will be documented through the EMR program 
Macpractice and we will utilize other data management methods such as google sheets 
-Any missing data will be accordingly documented 
-Missing data will be noted in results section/ likely to be reported in a table format 
-Data will be collected at the initial treatment including patient demographics, location of lesion, invasiveness of 
carcinoma and treatment settings. Each subsequent follow up visit will include data in the format of “clinical 
recurrence or no clinical recurrence of carcinoma” at each follow-up visit. If a biopsy is taken and is clear then “no 
histological recurrence” will be reported. If the biopsy shows evidence of carcinoma, then the detailed pathological 
results will be reported. Any additional necessary data including complications will be tracked and reported.  
-Written consent will be obtained by each patient prior to treatment and scanned electronically into their EMR 
patient file.  
-Thermal data and images will be collected through TopDon thermal imaging camera application on an IPad, then 
exporting in graph form to google sheets. 
 
Statistics 
-Subgroups will be defined by cancer type, cancer invasiveness, skin type, and gender 
 
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-The sample size is likely to be 20-100 participants as estimated by the established patients at the office of Bruce 
Robinson MD and the frequency of carcinoma diagnosis.  
-On a per-case basis, treatment is considered effective if there is no clinical/histological recurrence in 5 years.  
-For the study as a whole, the treatment is considered effective if the recurrence rate is lower or approximately equal 
to the comparison groups: other FDA approved/traditional treatment options. For example, studies have shown that 
after surgical excision, over 5 years, superficial BCC recurrence rate is between 2% and 5%, nodular BCC 2-8%, 
SCC in situ ~0.8%, and invasive SCC between 1.7% and 6.4%. And, most surgical excision recurrences occur 
within 2 years. Other methods such as electrodessication and curettage have higher recurrence rates. So, we would 
consider our treatment successful if our recurrence rates are lower or approximately equal to any of the approved 
treatment options.  
-Treatment is not randomized. Participation is determined by the patient’s willingness to participate. If they 
participate they are given the treatment. No placebos or control groups.  
 
Ethics, Privacy, and Pharmacovigilance Reporting 
-ethical consideration is important for this study. We use human participants. If not monitored closely, the skin 
cancers have a risk to progress and cause damage to the patient's skin at the affected area. Survival rate for BCCs 
and SCCs is almost 100% therefore there is a very low risk of death. We will be submitting our study for ethics 
approval prior to starting. 
-We will protect patient personal data and confidentiality in accordance with HIPAA guidelines. Our office already 
follows HIPAA and all employees are well informed of the policy. No PHI as outlined by HIPAA will be reported or 
shared from our study in any publications or shared with any individual not responsible for the direct care of the 
patient. Letters and/or numbers will replace names when referring to subjects when reporting or referring to data. 
Photos or videos taken of participants will not include identifying characteristics unless rights were signed off by the 
patient. Informed consent will be obtained prior to any individual's participation in our study. A detailed consent 
form will be reviewed with the patient and the patient will be required to sign before being treated. If the patient has 
caretakers or family members that are responsible for assistance with their care they will also be present in the 
review of consent.  
-Patients will be instructed of the importance of returning to the office for the scheduled follow ups. Patients will be 
closely tracked and monitored. We collect cell, home, mobile, and emergency numbers, emails, and addresses from 
all patients under our care. This provides multiple ways to contact patients. Patients will be instructed to make 
follow up appointments before leaving the office, if they don’t then we will call when they are due. Patients are 
always called, texted, and/or emailed prior to their appointments to confirm. No show patients will be contacted 
multiple times. If no response is given after multiple electronic attempts, then letters are mailed to patients. These 
letters outline the importance of returning to the office for care and the risks associated with not returning. If after all 
attempts to contact the patient are unsuccessful, they will be labeled as withdrawn from the study. This will be noted 
in our data. If the study is terminated, all participants will be closely monitored as outlined in the study protocol. If 
the site is terminated, participants will be instructed to find another dermatologist to track the recurrence of their 
 
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skin cancer. Medical records and research data will be sent to their new dermatologist once a patient signs a medical 
record release. Care will then be transferred over to their new dermatologist.  
-For adverse reactions/adverse events: All adverse reactions will be noted and reported in our study. A new plan of 
care will be designed for the patient ensuring the proper treatment of their skin cancer.  
-We plan to publish this study in a scientific journal. 
 
 
IRB APPROVED
05/16/2025