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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Neurofibromatosis 1 (NF1)Neurofibromatosis Type I
Interventions
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."

Trial Locations (1)

02114

Wellman Center for Photomedicine, Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

lead

Massachusetts General Hospital

OTHER