Clinical Trial: Dosing and Tolerability of Deoxycholic Acid Versus Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Dosing and Tolerability of Deoxycholic Acid Versus Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Brief Summary: This study will evaluate the tolerability and effectiveness of two treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas.
These treatments are: Kybella and Asclera 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 adverse 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 adverse event that requires treatment.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: November 01, 2023
Date Started: December 06, 2022
Date Completion: December 06, 2022
Last Updated: November 01, 2023
Last Verified: November 01, 2023