A Phase II Study of NFX-179 Gel in People with Cutaneous Neurofibromas

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Full Title

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Phase 2 Dose-Response Study to Determine Safety and Effectiveness of Two Concentrations of NFX-179 Gel in Subjects with Cutaneous Neurofibromas

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug NFX-179 in people with neurofibromatosis type I (NF1) with cutaneous neurofibromas (cNF) on the face, arms, and the front of the body. These growths are benign (non-cancerous) lesions that grow from small nerves in or just below the skin. They are the most common symptom of NF1.

NFX-179 is a skin gel. It is designed to penetrate the outer layer of skin and remove or reduce the size of cNF lesions. Participants in this study will be randomly assigned to receive low-dose NFX-179, higher-dose NFX-179, or a placebo (inactive drug).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have NF1 with at least 10 cNF lesions on the face, arms, and front of the body.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. Anna Piotrowski at 212-610-0483.

Protocol

22-053

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators