Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Cutaneous Neurofibroma

Treatments: Device: 1064nm laser; Device: 755nm Alexandrite Laser; Drug: Kybella

Study type: Interventional

Funder types: Other

Identifiers

NCT04730583

2020P004137

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Kybella Injection

Active Comparator group

Treatment:

Drug: Kybella

1064nm laser

Active Comparator group

Treatment:

Device: 1064nm laser

755nm laser

Active Comparator group

Treatment:

Device: 755nm Alexandrite Laser