A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Phase 2 Dose-Response Study To Determine Safety And Effexctiveness Of Two Concentrations Of Nfx-179 Gel In Subjects With Cutaneous Neurofibromas
Posted Date: Sep 22, 2022
- Investigator: Katherine Baquerizo Nole
- Specialties:
- Type of Study: Drug
Neurofibromatosis type I (NF1) is one of the most common genetic disorders, is not limited by a person's race or sex, and causes tumors along the nervous system which can grow anywhere on the body. The tumors are benign, but the severity of the disease varies widely. About 40% of patients experience moderate to severe disease that can manifest as hundreds of tumors distributed through out the body. This can have a dramatic and unpredictable effect on health-related quality of life and cause emotional and physical pain. This study will evaluate the efficacy, safety and tolerability of a topical gel to treat NF1. There is a potential therapeutic benefit of the gel to reduce tumor volume. This is a placebo-controlled study with 2:1 chance to receive the active drug instead of inactive gel. Study duration maximum of 242 days.
Criteria:
Participants Must Be 18 Years Old Or Older, Have Lesions On The Face And On The Trunk Or Upper Extremities, If Female Must Not Be Pregnant Or Planning A Pregnancy During The Study.
Keywords:
Cutaneous Neurofibroma, Efficacy/Safety/Tolerability, Topical Formulation
For More Information:
Jordan Sambrookes
(513) 558-0951
perryj8@ucmail.uc.edu