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

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.

Timeline

Start

2021-09-29

Primary completion

2023-10-02

Completion

2023-10-02

Outcome

Met primary endpoint

registry analysis (other test); NFX-179 Topical Gel Vehicle vs NFX-179 Topical Gel 1.5%; p = 0.0337; Chi-squared NCT05005845 ↗

Drugs

Indications