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

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL

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

Brief 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..

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Device based treatment will be considered tolerable if <40% of participants treated have a >grade 2 adverse event (AE).
A grade 2 AE is defined as an event that requires treatment.

Original Primary Outcome: Device based treatment will be considered tolerable if <40% of participants treated have a >grade 2 adverse event (AE).
A grade 2 AE is defined as an event that requires treatment.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: November 01, 2023
Date Started: December 01, 2023
Date Completion: December 01, 2023
Last Updated: November 13, 2023
Last Verified: November 01, 2023