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Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

NCT04730583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Neurofibroma

Interventions

DRUG

Kybella

Injection into the cutaneous Neurofibromas lesion

DEVICE

1064nm laser

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion

DEVICE

755nm Alexandrite Laser

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Sponsors & Collaborators

Principal Investigators

  • R. Rox Anderson, MD · Wellman Center for Photomedicine, Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730583 on ClinicalTrials.gov