Overview

Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Johns Hopkins University
Treatments:
Deoxycholic Acid
Criteria
Inclusion Criteria:

- Adult males and females ≥18 years of age

- Have a diagnosis of Neurofibromatosis Type 1

- Patients must be seeking treatment for cutaneous Neurofibromas

- Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3
untreated) that are visible and measure between 2-4mm in size.

- Able and willing to comply with all visit, treatment and evaluation schedules and
requirements

- Able to understand and provide written informed consent

- Access to a Smart Phone to be able to take and upload photographs to an application

Exclusion Criteria:

- Patients who are undergoing other treatment modalities or investigational agents for
their cNF lesions

- Individuals who cannot give informed consent or adhere to study schedule

- Actively tanning during the course of the study

- Adverse reactions to compounds of any external agent (e.g., gels, lotions or
anesthetic creams) required for use in the study, if no alternative to the said agent
exists;

- Known allergy to injectable anesthetics or deoxycholic acid

- Any condition which, in the Investigator's opinion, would make it unsafe (for the
participant or study personnel) to treat the participant as part of this research
study;

- Pregnant females, due to possible discomfort with the procedure even though the
procedure is localized and there is no new drug.