Neurofibroma > 755nm Alexandrite Laser

Device-Based Therapies for Neurofibromatosis

Recruiting in Palo Alto (17 mi)

Overseen By R. Rox Anderson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.

Eligibility Criteria

Adults over 18 with Neurofibromatosis Type 1 seeking treatment for visible cutaneous neurofibromas (skin growths) can join. They need at least six paired growths measuring 2-4mm to treat and compare. Participants must follow the study plan, give consent, and use a smartphone for photo updates. Pregnant individuals, those tanning or using other treatments, allergic to certain anesthetics or deoxycholic acid cannot join.

Participant Groups

The trial is testing three FDA-approved therapies on skin growths caused by Neurofibromatosis Type 1: two types of lasers (1064nm and 755nm Alexandrite) and Kybella injections. Each patient will have one treated spot and one untreated control spot to compare effectiveness.

Group I: 1064nm laser Active Control 1 Intervention

Group II: Kybella Injection Active Control 1 Intervention

Group III: 755nm laser Active Control 1 Intervention

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Wellman Center for Photomedicine, Massachusetts General Hospital Boston, MA

Who is running the clinical trial?

Massachusetts General Hospital Lead Sponsor

Johns Hopkins University Collaborator

References