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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific laser treatment (Alexandrite Laser) can reduce and improve the appearance of skin bumps (cutaneous neurofibromas) in people with Neurofibromatosis Type 1 (NF1), a genetic disorder. Researchers aim to determine if using a laser, possibly with a cooling method, is both effective and gentle on the skin. Participants will receive up to six monthly laser treatments and provide feedback on their experience. This trial suits adults with NF1 who have visible, treatable, and photographable skin bumps, especially on the trunk, arms, or legs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance 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.

What prior data suggests that the Alexandrite Laser is safe for treating Neurofibromatosis Type 1?

Research shows that the Alexandrite Laser is generally gentle on the skin. Studies have found that this laser treatment usually causes only mild skin reactions. In one study with 19 adults, different treatments were tested on small skin growths called cutaneous neurofibromas (cNFs), and the Alexandrite Laser proved to be one of the least painful options.

The treatment is also considered safe. Other research found that using the Alexandrite Laser for skin conditions like café-au-lait macules (brown birthmarks) in children is both safe and effective, indicating that the laser does not cause major side effects.

Overall, evidence shows that the Alexandrite Laser is safe for use on the skin and causes minimal discomfort. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cutaneous neurofibromas, which often include surgical removal or topical medications, the Alexandrite Laser offers a non-invasive approach. This laser targets the pigment in the neurofibromas with a specific wavelength of 755 nm, which could potentially reduce these skin lesions more precisely and safely. Researchers are excited about this treatment because it might minimize skin damage and provide a quicker recovery time compared to traditional methods.

What evidence suggests that Alexandrite Laser might be an effective treatment for NF1?

Research has shown that the Alexandrite Laser can effectively treat skin growths called cutaneous neurofibromas (cNFs) in people with Neurofibromatosis Type 1 (NF1). In this trial, participants will receive treatment with the Alexandrite Laser on selected cNFs, while a complementary region of cNFs will serve as an untreated control group. Studies have found that the Alexandrite Laser can significantly reduce or remove these skin tumors without causing scars or serious side effects. It is also considered one of the least painful treatment options. Importantly, this treatment does not cause new cNFs to grow, which is a positive result. Overall, this laser treatment has shown promise in improving the appearance and size of these skin growths. ^{1 2 3 5 6}

Who Is on the Research Team?

Richard R. Anderson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06934928?term=AREA%5BConditionSearch%5D(%22Neurofibromatosis%22)&rank=2

Assessing the Efficacy of Repeat, Monthly Treatments ...

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38086517/

Noninvasive treatment of cutaneous neurofibromas (cNFs)

Results: There was no scarring or adverse events > grade 2. Each modality significantly (P < .05) reduced or cleared cNFs, with large variation between tumors ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0190962223032899

Noninvasive treatment of cutaneous neurofibromas (cNFs)

This prospective randomized trial evaluated 4 therapeutic approaches currently FDA-cleared for other dermatological indications and modified for treating cNFs.

4.

healio.com

healio.com/news/dermatology/20240105/nonsurgical-treatments-may-be-effective-option-for-cutaneous-neurofibromas

Nonsurgical treatments may be effective option for ...

Deoxycholate and alexandrite laser were both effective and the least painful options studied. ... “People with neurofibromatosis type 1 (NF1) ...

5.

jaad.org

jaad.org/article/S0190-9622(23)03289-9/abstract

Noninvasive treatment of cutaneous neurofibromas (cNFs)

Alexandrite laser and deoxycholate were fast and least painful; 980 nm laser was most painful. Growth of cNFs was not stimulated by treatment(s) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6771696/

Treatment of Café‐Au‐Lait Spots Using Q‐Switched ...

Q‐switched alexandrite laser (755 nm) therapy is safe and highly effective for CALMs in children, and the number of treatments affects the treatment efficacy.