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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
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.
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.
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, United States
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment will be considered tolerable if \<40% of participants treated have a \>Grade 2 CTCAE v5 adverse event (AE).
Time frame: Anytime between initiation of treatment and study completion.
Patient Global Assessment of cNF Improvement (Likert Scale)
Patient rates degree of change of treated cNFs on a scale from -3 (very much worse) to 3 (very large improvement).
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Clinician Global Assessment of cNF Improvement (Likert Scale)
Clinician rates degree of change of treated cNFs on a scale from -3 (very much worse) to 3 (very large improvement).
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
VAS Pain Scale
Participants will be asked to rate their pain using a visual analog scale (0 to 10) at each treatment visit and 1 week after each treatment.
Time frame: Baseline, every 30 days (up to Day 240).
Patient Satisfaction
Satisfaction with each treatment modality is rated from 1 (very unsatisfied) to 5 (very satisfied).
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Rate of Healing
Measured clinically via photography completed by a member of the study team at baseline, and all in-person visits.
Time frame: Baseline, every 30 days (up to Day 240).
cNF Appearance (Height)
Clinically completed 3D Cherry Imaging. Change from baseline in height of cNFs.
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
cNF Appearance (Volume)
Clinically completed 3D Cherry Imaging. Change from baseline in volume of cNFs.
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
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