At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Clinically diagnosed NF1
- ✓≥10 target cutaneous neurofibromas: preferably 2 on face and 8 on anterior trunk/upper extremities (or ≥1 on face with 9 on trunk/extremities)
- ✓Target neurofibromas on face: 5–14 mm length, 5–14 mm width, ≥2 mm height; dome-shaped, non-pedunculated, Physician's Tumor Assessment grade ≥2
- ✕Prior topical corticosteroids, prescription retinoids, >5% alpha-hydroxy acids, fluorouracil, or imiquimod within 30 days on/near target lesions
- ✕Prior laser, light therapy (IPL, PDT), or energy-based therapy within 180 days on/near target lesions
- ✕Any prior topical or systemic MEK inhibitors or BRAF inhibitors (lifetime exclusion)
- ✕Systemic retinoids (etretinate, isotretinoin) within 90 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating NFX-179 gel and Vehicle gel for Cutaneous Neurofibroma and Neurofibromatosis 1. Completed, enrolled 199 participants across 23 sites.
Detailed 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.
Study Details
Timeline
Interventions
NFX-179 topical gel is the active investigational product being studied
NFX-179 vehicle gel is the placebo comparator for this study