Fractional Laser + Tirbanibulin for Skin Cancer

Overseen By Gillian Nanni, Research Coordinator, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bruce Robinson, MD

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating skin cancer, specifically squamous and basal cell carcinomas. It examines the use of a fractional laser, either alone or with an ointment called tirbanibulin, to determine their effectiveness in treating cancer while preserving cosmetic appearance. The goal is to provide a less invasive alternative to surgery. Candidates for this trial include individuals with biopsy-confirmed squamous or basal cell carcinoma that has not been treated by other methods. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fractional laser treatments are generally well-tolerated by patients. One study reported common skin changes, such as redness in 74% of cases and changes in skin color in 30% of cases, without any serious side effects. This suggests that the treatment is generally safe, with side effects primarily affecting the skin.

For those using both fractional laser and tirbanibulin ointment, past patients have experienced positive outcomes. The absence of specific data on serious side effects suggests that the combination is likely safe, especially since the FDA has already approved tirbanibulin for certain skin conditions. Overall, these treatments appear to have a good safety record, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine fractional laser therapy with tirbanibulin ointment, potentially offering a powerful one-two punch against skin cancer. Unlike traditional treatments, such as surgical excision or cryotherapy, fractional laser therapy targets the cancerous tissue with precision, minimizing damage to surrounding healthy skin. Tirbanibulin, a newer topical agent, works by disrupting protein production in cancer cells, which could enhance the effectiveness of the laser treatment. This combination may provide a more targeted and less invasive option for patients, with the potential for quicker recovery and fewer side effects.

What evidence suggests that this trial's treatments could be effective for skin cancer?

This trial will compare the effectiveness of two treatment approaches for skin cancer. Research has shown that using fractional lasers with tirbanibulin ointment, which participants in one arm of this trial will receive, can effectively treat certain skin cancers, such as basal and squamous cell carcinomas. In one study, 30 skin cancers were successfully treated, demonstrating the potential benefits of this combination. Meanwhile, fractional lasers alone, which participants in another arm of this trial will receive, have improved skin appearance in 76% of patients, with many noticing better cosmetic results. Tirbanibulin ointment targets skin cells, enhancing the treatment's effectiveness. Overall, these treatments aim to reduce the need for surgery and improve skin appearance. ^{1 2 6 7 8}

Who Is on the Research Team?

Bruce Robinson, MD

Principal Investigator

Bruce Robinson, MD

Are You a Good Fit for This Trial?

This trial is for individuals with biopsy-confirmed basal or squamous cell carcinomas of the skin that haven't been treated before. It's designed to find a less invasive treatment option that could help improve cosmetic outcomes.

Inclusion Criteria

My skin cancer has been confirmed by biopsy and not treated yet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional laser therapy and may apply tirbanibulin ointment for five nights

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 visit (in-person) at 1 month, then biannual visits

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Laser
• Tirbanibulin Ointment

Trial Overview The study tests fractional laser therapy followed by Tirbanibulin ointment application on skin cancer lesions. The lasers used are thulium and erbium, and the ointment is applied over five nights post-treatment.

How Is the Trial Designed?

Group I: Fractional Laser and Tirbanibulin Ointment Active Control 2 Interventions

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

Group II: Fractional Laser Only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Bruce Robinson, MD

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5790423/

An Analysis of Laser Therapy for the Treatment of ... Although prognosis is generally excellent, approximately 4% metastasize, and 1.5% to 2% result in mortality.

2. jaad.org jaad.org/article/S0190-9622(14)02219-1/fulltext

Treatment of superficial basal cell carcinoma and ... Cosmesis was rated as “better than before treatment” by 76% (23/30) of patients and “same as before treatment” by the remainder. Fig 1 Squamous cell carcinoma ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11473590/

Utilizing fractional lasers and tirbanibulin ointment to treat ... Studies have found that non-ablative fractional laser therapy can be an effective treatment for actinic keratoses [19]. Researchers also found ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424000265

Image Guidance is Associated with Improved Freedom ... This study demonstrates that IGSRT is associated with remarkably low recurrence rates, which are statistically significantly improved from the previous ...

5. healio.com healio.com/news/dermatology/20160803/ablative-fractional-laser-with-topical-fluorouracil-effective-for-some-nonmelanoma-skin-cancers

Ablative fractional laser with topical fluorouracil effective for ... The overall treatment success rate was 79% (95% CI, 67-96). The success rate for those with SCC in situ was 92% and the success rate was 67% for ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13864-z

Updated results of 3050 non-melanoma skin cancer (NMSC ... Hernández-Machin et al. reported 5-year absolute LC rates of 94.4% for BCC lesions and 92.7% for SCC lesions. With these results, the authors ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8483749/

Randomized controlled trial of fractionated laser ... Though the treatments resulted in significant levels of wounding (Figure 6B), minimal discomfort and no scarring was noted in the participants. Side effects ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07010692?term=TIRBANIBULIN&rank=6

Treating Basal and Squamous Cell Carcinomas With ... Every skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser. What is the study measuring? Primary Outcome ...