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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
Patients must be seeking treatment for cutaneous Neurofibromas
Have a diagnosis of Neurofibromatosis Type 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am seeking treatment for skin tumors related to Neurofibromatosis.
Select...
I have been diagnosed with Neurofibromatosis Type 1.
Select...
I have at least 6 visible skin growths between 2-4mm in size.

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

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

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
2,918 Previous Clinical Trials
13,192,815 Total Patients Enrolled
13 Trials studying Neurofibroma
1,131 Patients Enrolled for Neurofibroma
Johns Hopkins UniversityOTHER
2,242 Previous Clinical Trials
14,816,617 Total Patients Enrolled
6 Trials studying Neurofibroma
1,640 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards do people face when exposed to 755nm laser radiation?

"Due to the limited amount of research on efficacy and safety, 755nm laser was rated one out of three in terms."

Answered by AI

Do I meet the requirements to participate in this research?

"To be eligible for this clinical experiment, a person must possess neurofibroma and range in age from 18 to 85 years old. This study is aiming to recruit approximately 20 individuals."

Answered by AI

Is elderly participation acceptable in the current experiment?

"This clinical trial allows for participants between the ages of 18 and 85, as per its inclusion criteria."

Answered by AI

What is the accepted patient capacity for this research trial?

"Affirmative. Clinicaltrials.gov reveals that this trial, which launched on June 2nd 2021 is still actively recruiting participants for a total of 20 individuals at 1 medical centre across the country."

Answered by AI

Could you provide an overview of past research involving 755nm laser?

"Currently, there are 4 ongoing clinical examinations into 755nm laser with no trials in progression 3. A significant portion of these research projects are located near South Brisbane, Queensland while the rest can be found over 9 distinct sites."

Answered by AI

Does this experiment have room for additional participants?

"According to the clinicaltrials.gov website, this research project is currently enrolling participants who meet its criteria. It was initially published on June 2nd 2021 and amended as recently as August 10th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

~4 spots leftby Dec 2024