NCT05005845

NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: NFlection Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 gel in participants with cNF. At Visit 1 (Screening visit), the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the participant's face, anterior trunk, or upper extremities. Two Target cNFs must be on the face and 8 must be on the anterior trunk or upper extremities. The study medication will be applied topically once daily to the Target cNFs for 182 days (26 weeks). During the duration of the study participants will be evaluated for safety and efficacy.

Conditions

• Cutaneous Neurofibroma
• Neurofibromatosis 1

Interventions

Type	Name	Description
DRUG	NFX-179 gel	NFX-179 topical gel is the active investigational product being studied
DRUG	Vehicle gel	NFX-179 vehicle gel is the placebo comparator for this study

Timeline

• Start date: 2021-09-29
• Primary completion: 2023-10-02
• Completion: 2023-10-02
• First posted: 2021-08-16
• Last updated: 2026-02-17
• Results posted: 2026-02-17

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study