NCT06934928

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-04-18
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study