Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Suspended
- People taking part
- 10 people, planned
- Starts
- Jan 2027
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- GentleMax Pro (with skin cooling)
- GentleMax Pro (without skin cooling)
- Record updated
- 4 June 2026
- Why it stopped
- Study is currently not funded at this time.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Where in United States
- Wellman Center for Photomedicine, Massachusetts General HospitalBoston, United States
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 2 groups in the trial
- Treated cutaneous neurofibromas (cNFs)Existing treatment, for comparison
Participants will receive treatment with laser at a wavelength of 755 nm to the cutaneous Neurofibromas lesion.
Treatment: GentleMax Pro (with skin cooling) and GentleMax Pro (without skin cooling)
- Control cutaneous neurofibromas (cNFs)No study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1 Associated Cutaneous Neurofibromas (cNFs)
- Record updated
- 4 June 2026