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

NCT ID: NCT06934928

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treated cutaneous neurofibromas (cNFs)

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

Group Type: ACTIVE_COMPARATOR

GentleMax Pro (with skin cooling)

Intervention Type: 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.

GentleMax Pro (without skin cooling)

Intervention Type: 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.

Control cutaneous neurofibromas (cNFs)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GentleMax Pro (with skin cooling)

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.

Intervention Type: DEVICE

GentleMax Pro (without skin cooling)

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.

Intervention Type: DEVICE

Other Intervention Names

Alexandrite Laser; 755 nm Laser; Dynamic Cryogen Spray Cooling Device; DCD; Alexandrite Laser; 755 nm Laser

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard Rox Anderson, MD

Director, Wellman Center for Photomedicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard R. Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Clinical Research Coordinator

Role: CONTACT

wellmancrc@partners.org

617-724-2168

Facility Contacts

Gina Hickford

Role: primary

ghickford@mgh.harvard.edu

617-726-3308

Fernanda Sakamoto, MD, PhD

Role: backup

fsakamoto@mgh.harvard.edu

617-724-5329

Other Identifiers

2025P000283

Identifier Type: -

Identifier Source: org_study_id