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