NCT06132165

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of skin cooling in increasing tolerability of four 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..

Conditions

• Neurofibromatosis 1

Interventions

Type	Name	Description
DRUG	Deoxycholic Acid	Injection into the cutaneous Neurofibromas lesion.
DRUG	Polidocanol	Injection into the cutaneous Neurofibromas lesion.
DEVICE	1064nm Nd:YAG 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: 2024-03-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-11-15
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

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