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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of using Alexandrite Laser treatments for people with Neurofibromatosis Type 1 (NF1), specifically for a type of growth called cutaneous neurofibromas (cNFs). The researchers want to find out if up to six monthly treatments can help reduce the size of these growths by more than half and improve their appearance. Participants will also be asked about their pain levels and satisfaction with the treatment, and some may have small samples taken from the treated areas to better understand how the tumors respond to the laser.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of NF1. They should have at least 12 visible cNFs that are 2 mm or larger in specific areas where the laser can be applied. Participants must also be willing to follow the study schedule and provide consent. During the trial, they will receive monthly laser treatments, complete surveys, and undergo imaging to track changes in their cNFs. It's important to note that individuals with certain skin types, those who are pregnant, or who have other specific medical conditions may not be able to participate.

Gender

ALL

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.