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

NCT06132165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-11-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Richard R Anderson, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06132165 on ClinicalTrials.gov