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

Last updated: March 3, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Suspended

Phase

N/A

Condition

Brain Tumor

Warts

Treatment

GentleMax Pro (without skin cooling)

GentleMax Pro (with skin cooling)

Clinical Study ID

NCT06934928
2025P000283
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 plexiformneurofibromas

  • 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 behindthe 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 treatedwith DCD) that are visible and measure at least 2 mm in size in the target treatmentarea. The target treatment area must be amenable to both laser treatments andsurveillance with digital and 3D photography. Preferred locations are trunk (back orchest), arms and legs.

  • Participant is able and willing to comply with all visit, treatment, and evaluationschedules and requirements.

  • Participant is able to understand and provide written informed consent.

  • Participant has no concurrent injury or wound in the target area.

Exclusion

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 itunsafe (for the participant or study personnel) to treat the participant as part ofthis research study.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: GentleMax Pro (without skin cooling)
Phase:
Study Start date:
January 01, 2027
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Wellman Center for Photomedicine, Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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