Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)

NCT06934928 | Suspended FDA Device

• 1 other identifier: 2025P000283
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurofibromatosis 1 (NF1); Neurofibromatosis Type I

Keywords

Neurofibromatosis; NF1; Cutaneous Neurofibroma; cNF; GentleMax Pro

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Treatment will be considered tolerable if \<40% of participants treated have a \>Grade 2 CTCAE v5 adverse event (AE).

  Anytime from initiation of treatment through study completion, an average of 8 months.

Secondary Outcomes (7)

• Patient Global Assessment of cNF Improvement (Likert Scale)

  Baseline, Day 90, and 30 days after final treatment (up to Day 240).

• Clinician Global Assessment of cNF Improvement (Likert Scale)

  Baseline, Day 90, and 30 days after final treatment (up to Day 240).

• VAS Pain Scale

  Baseline, every 30 days (up to Day 240).

• Patient Satisfaction

  Baseline, Day 90, and 30 days after final treatment (up to Day 240).

• Rate of Healing

  Baseline, every 30 days (up to Day 240).

Other Outcomes (1)

• Biologic Effect/Histology

  3 months after final treatment session.

Study Arms (2)

Treated cutaneous neurofibromas (cNFs)

ACTIVE COMPARATOR

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

Device: GentleMax Pro (with skin cooling); Device: GentleMax Pro (without skin cooling)

Control cutaneous neurofibromas (cNFs)

NO 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.

Interventions

GentleMax Pro (with skin cooling) DEVICE

Treatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin. A negative pressure hand piece provides temporary, mild suction (\~1/2 atm) before laser exposure. A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration. The laser system includes a dynamic cryogen spray cooling device (DCD) for epidermal protection. A spurt of cryogen cools the epidermis just before arrival of the treatment laser pulse.

Also known as: Alexandrite Laser, 755 nm Laser, Dynamic Cryogen Spray Cooling Device, DCD

Treated cutaneous neurofibromas (cNFs)

GentleMax Pro (without skin cooling) DEVICE

Treatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin. A negative pressure hand piece provides temporary, mild suction (\~1/2 atm) before laser exposure. A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration.

Also known as: Alexandrite Laser, 755 nm Laser

Treated cutaneous neurofibromas (cNFs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is an adult ≥18 years of age.
• Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
• Family history of NF1
• Six or more light brown ("cafe-au-lait") spots on the skin
• Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
• Freckling under the arms or in the groin area
• Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
• A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
• Tumor on the optic nerve that may interfere with vision
• Participant is seeking treatment for cNF.
• Participants must have ≥ 12 paired cNF (6 to be treated without DCD, 6 to be treated with DCD) that are visible and measure at least 2 mm in size in the target treatment area. The target treatment area must be amenable to both laser treatments and surveillance with digital and 3D photography. Preferred locations are trunk (back or chest), arms and legs.
• 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.
• Participant has no concurrent injury or wound in the target area.

You may not qualify if:

• Participant cannot give informed consent or adhere to study schedule.
• Participant is Fitzpatrick skin type V-VI.
• Participant is actively tanning during the course of the study.
• For female participants: participant is pregnant.
• Participant has any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Neurofibromatoses

Interventions

Lasers, Solid-State; Lasers

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Richard R. Anderson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Wellman Center for Photomedicine

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 18, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2025-04

Locations

US (1)