Alexandrite Laser for NF1

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Disqualifiers: Fitzpatrick skin type V-VI, Pregnant, Actively tanning, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

10 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Alexandrite Laser treatment for NF1?

The Alexandrite Laser has shown effectiveness in treating skin conditions like nevus of Ota and facial pigmentation, with many patients experiencing significant improvement. This suggests it may also be beneficial for similar skin-related issues in NF1. ^{1 2 3 4 5}

Is the Alexandrite Laser generally safe for use in humans?

The Alexandrite Laser is generally considered safe for treating skin conditions like pigmentary lesions and facial rejuvenation, but accidental exposure can cause eye-related issues, so protective measures are important. ^{2 4 6 7 8}

How does the Alexandrite Laser treatment for NF1 differ from other treatments?

The Alexandrite Laser treatment is unique because it uses a laser that can be tuned to different wavelengths, allowing for precise targeting of affected areas. This laser technology is highly efficient and can be adjusted for specific needs, which is not a feature of many other treatments for NF1. ^{9 10 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the tolerability and effectiveness of multiple treatments of Alexandrite (755 nm) Laser in those with Neurofibromatosis Type 1 (NF1) Cutaneous Neurofibromas (cNFs). The main questions it aims to answer are: Will performing up to 6 months of treatment sessions with alexandrite laser will result in tolerable local skin reactions and reduction in both individual cNF size by \>50% as well as improved cNF appearance in the treated field? If there is a comparison group: Researchers will compare laser treatment with cooling to both laser treatment without cooling and an untreated control see if laser treatments are effective and if cooling makes treatment more tolerable. Participants will: * Receive up to 6 monthly laser treatments. * Complete surveys asking about pain during and after treatments. * Complete surveys asking about satisfaction with the treatments. * Undergo 2D photography and 3D imaging of treatment areas. * Optionally, receive biopsies of up to 6 treated lesions to investigate characteristics of tumors that respond well to treatment as well as non-respondent tumors.

Research Team

Richard R. Anderson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals with Neurofibromatosis Type 1 (NF1) who have skin tumors called Cutaneous Neurofibromas (cNFs). Participants will undergo up to six monthly laser treatments and complete surveys about their pain and satisfaction. They must be eligible based on specific criteria not provided here.

Inclusion Criteria

Participant is able and willing to comply with all visit, treatment, and evaluation schedules and requirements

Participant is able to understand and provide written informed consent

I have been diagnosed with NF1, either through genetic testing or by having symptoms like light brown spots, tumors, or freckling.

Exclusion Criteria

Participant is Fitzpatrick skin type V-VI

Participant is actively tanning during the course of the study

Participant has any condition which, in the Investigator's opinion, would make it unsafe to treat the participant as part of this research study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 6 monthly laser treatments with Alexandrite laser for NF1-associated cutaneous neurofibromas

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cNF appearance and patient satisfaction

3 months

2 visits (in-person)

Treatment Details

Interventions

• Alexandrite Laser

Trial Overview The study tests the effectiveness of Alexandrite Laser treatments, with or without skin cooling, on reducing the size and improving the appearance of cNFs in NF1 patients over a period of up to six months. It includes surveys, imaging, and optional biopsies.

Participant Groups

Group I: Treated cutaneous neurofibromas (cNFs) Active Control 2 Interventions

Participants will receive treatment with laser at a wavelength of 755 nm to the cutaneous Neurofibromas lesion.

Group II: Control cutaneous neurofibromas (cNFs) Active Control 1 Intervention

A complementary region of cNFs of similar characteristics to the treatment area in the same body region will be selected to serve as an untreated control group.

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Factors affecting response, number of laser sessions and complications in nevus of Ota treated by Q-switched alexandrite laser: a retrospective study. [2017]

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

Chorioretinal anastomosis secondary to inadvertent alexandrite laser exposure. [2023]

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

Use of a variable long-pulse alexandrite laser in the treatment of facial telangiectasia. [2010]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Color analysis of nevus of Ota for evaluation of treatment with a Q-switched alexandrite laser. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Laser-induced macular neovascularization following accidental exposure to Alexandrite laser and excellent response to anti-VEGF: A case report. [2022]

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

CHOROIDAL NEOVASCULARIZATION SECONDARY TO ALEXANDRITE LASER EXPOSURE. [2022]

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

Diode-side-pumped Alexandrite slab lasers. [2018]

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

Alexandrite lasers with blue-diode-pumping. [2023]

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

High efficiency >26 W diode end-pumped Alexandrite laser. [2018]

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

Diode-pumped Q-switched Alexandrite laser in single longitudinal mode operation with Watt-level output power. [2019]

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

High-energy acousto-optic Q-switched alexandrite laser with wavelength tunable fundamental and UV second harmonic generation. [2023]