← Back to Search

Laser Therapy

Device-Based Therapies for Neurofibromatosis

Phase 1
Waitlist Available
Led By R. Rox Anderson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will test how well four different treatments work on neurofibromas, growths on the nervous system.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include discomfort at the treatment site, skin reactions like redness or swelling from lasers or injections, potential allergic reactions if sensitive to anesthetic creams used during procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Clinician Reported Outcomes
Patient Report Outcomes

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: 1064nm laserActive Control1 Intervention
Group II: Kybella InjectionActive Control1 Intervention
Group III: 755nm laserActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,291 Total Patients Enrolled
13 Trials studying Neurofibroma
1,131 Patients Enrolled for Neurofibroma
Johns Hopkins UniversityOTHER
2,326 Previous Clinical Trials
14,874,939 Total Patients Enrolled
7 Trials studying Neurofibroma
1,664 Patients Enrolled for Neurofibroma
R. Rox Anderson, MDPrincipal InvestigatorWellman Center for Photomedicine, Massachusetts General Hospital
4 Previous Clinical Trials
249 Total Patients Enrolled

Media Library

755nm Alexandrite Laser (Laser Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04730583 — Phase 1
Neurofibroma Clinical Trial 2023: 755nm Alexandrite Laser Highlights & Side Effects. Trial Name: NCT04730583 — Phase 1
~0 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top