Multiple Treatments for Skin Tumors

Overseen By Devon Gunter

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Thromboembolic diseases, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 months

10 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antiplatelet or anticoagulant therapy, you may not be eligible to participate.

What data supports the effectiveness of the 1064nm Nd:YAG Laser, 755nm Alexandrite Laser, Asclera, and Kybella treatment for skin tumors?

Research shows that the 1064nm Nd:YAG laser is promising for treating various skin tumors, including benign and malignant types, and is effective for basal cell carcinoma. The 755nm Alexandrite laser is effective for improving skin pigmentation and rejuvenation, with many patients reporting significant improvement. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The 1064nm Nd:YAG and 755nm Alexandrite lasers have been studied for various skin conditions and are generally considered safe, with low rates of adverse effects like changes in skin color or scarring. No severe adverse events were reported in studies involving these lasers for hair removal and pigmentary disorders. ^{4 6 7 8 9}

How does the 1064nm Nd:YAG Laser treatment for skin tumors differ from other treatments?

The 1064nm Nd:YAG Laser is unique because it can treat a wide range of skin tumors, including benign, semi-malignant, and malignant types, with precision and minimal invasiveness. It allows for outpatient procedures and can be used on large tumors in sensitive areas, offering good cosmetic results compared to traditional methods. ^{2 3 10 11 12}

What is the purpose of this trial?

This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site. This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place.

Research Team

Richard R Anderson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals with Neurofibromatosis Type 1 who have skin tumors known as Cutaneous Neurofibromas. Participants should be willing to undergo multiple treatment sessions and allow for a control site on their body to remain untreated for comparison.

Inclusion Criteria

I have at least 6 matching skin growths on my trunk, arms, or legs, each 2-8mm in size.

I have been diagnosed with NF1 either through genetic testing or because I have symptoms like skin spots, tumors, or freckles.

I am seeking treatment for cutaneous neurofibromatosis.

Exclusion Criteria

Actively tanning during the study

Known allergy to deoxycholic acid or polidocanol

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four FDA-approved treatments for Neurofibromatosis Type 1 Cutaneous Neurofibromas, with three treatment visits. If minimal improvement is observed, crossover treatment with the most effective option is offered, followed by three additional treatment visits.

5 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 2, 5, and if applicable, 6, 7, and 10 months post-treatment.

7 months

Multiple visits (in-person)

Treatment Details

Interventions

• 1064nm Nd:YAG Laser
• 755nm Alexandrite Laser
• Asclera
• Kybella

Trial Overview The study tests the effectiveness of four FDA-approved treatments: two types of lasers (1064nm Nd:YAG and 755nm Alexandrite) and injections (Kybella and Asclera). Patients will receive repeated monthly treatments, with an option to switch if there's no improvement after three visits.

Participant Groups

Group I: Asclera Injection Active Control 1 Intervention

Asclera is sterile 1% polidocanol provided in a 2 mL single-use vial.

Group II: 755nm laser Active Control 1 Intervention

The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Group III: Kybella Injection Active Control 1 Intervention

Kybella is sterile 1% deoxycholic acid provided in a 2 mL single-use vial.

Group IV: 1064nm laser Active Control 1 Intervention

The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

In a study involving 10 patients with basal cell carcinoma (BCC), treatment with a pulsed 1064 nm Nd:YAG laser resulted in a 92% rate of complete histologic clearance after just one session, indicating high efficacy for this non-surgical approach.

The laser treatment was well tolerated with no significant adverse events or scarring reported, suggesting it is a safe alternative to traditional surgical methods for treating BCC on the trunk and extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1064 nm long-pulsed Nd:YAG laser treatment of basal cell carcinoma. Ortiz, AE., Anderson, RR., Avram, MM.[2015]

Nd:YAG laser therapy was successfully used to treat 94 skin lesions in 51 patients, demonstrating its effectiveness for various skin tumors, including basal-cell carcinomas and actinic keratosis.

The treatment is advantageous as it can often be completed in a single outpatient procedure, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Nd:YAG laser for treatment of basal-cell carcinomas and some premalignant conditions]. Rubisz-Brzezińska, J., Bendkowski, W.[2007]

References

1. England pubmed.ncbi.nlm.nih.gov

Photorejuvenation using long-pulsed alexandrite and long-pulsed neodymium:yttrium-aluminum-garnet lasers: a pilot study of clinical outcome and patients' satisfaction in Koreans. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of benign, semimalignant, and malignant skin tumors with the Nd:YAG laser. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Neodymium:YAG laser in dermatologic therapy]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

1064 nm long-pulsed Nd:YAG laser treatment of basal cell carcinoma. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Side-by-side Comparison of a Picosecond 755-nm Alexandrite Laser and a Quality-switched 1064-nm Neodymium-doped Yttrium Aluminum Garnet Laser in the Treatment of Argyria. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of the Treatment of Melasma Using a Fractional Long-Pulsed Alexandrite Laser in Korean Patients. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of efficacy and safety of a novel 755-nm diode laser with conventional 755-nm alexandrite laser in reduction of axillary hairs. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Comparing the efficacy and safety of Q-switched and picosecond lasers in the treatment of nevus of Ota: a systematic review and meta-analysis. [2021]

10. Poland pubmed.ncbi.nlm.nih.gov

[Use of Nd:YAG laser for treatment of basal-cell carcinomas and some premalignant conditions]. [2007]

11. Germany pubmed.ncbi.nlm.nih.gov

[The neodymium YAG laser: its application in dermatology]. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Neodymium YAG laser therapy in dermatology]. [2007]