NCT04730583

Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-06-02
• Primary completion: 2024-04-19
• Completion: 2024-04-19
• First posted: 2021-01-29
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study