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Topical Gel

0.5% NFX-179 gel for Neurofibroma

Phase 2
Waitlist Available
Research Sponsored by NFlection Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 182 days

Summary

This trial tests a medicated gel called NFX-179 on people with benign skin tumors known as cutaneous neurofibromas. The gel is applied to the skin to help reduce the size or appearance of these tumors.

Eligible Conditions
  • Neurofibromas
  • Neurofibromatosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~182 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 182 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and effectiveness of once daily NFX-179 gel treatment for 182 days measured by local tolerability assessments, safety laboratory tests, and target cNF volume reduction
Safety of once daily NFX-179 gel treatment for 182 days by adverse events and serious adverse events assessments
Secondary study objectives
Percent change in cNF volume over 182 days
Percent of subjects with at least 50% Target cNF volume reduction after 182 days
Physician's Tumor Assessment of Target cNF severity over 182 days
+1 more
Other study objectives
Patient Reported Outcome Measure to assess Target cNF symptoms over 182 days

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 0.5% NFX-179 gelActive Control1 Intervention
Topical gel applied once daily to target cNFs
Group II: 1.5% NFX-179 gelActive Control1 Intervention
Topical gel applied once daily to target cNFs
Group III: Vehicle gelPlacebo Group1 Intervention
Topical gel applied once daily to target cNFs

Who is running the clinical trial?

NFlection Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Neurofibroma
48 Patients Enrolled for Neurofibroma

Media Library

NFX-179 gel (Topical Gel) Clinical Trial Eligibility Overview. Trial Name: NCT05005845 — Phase 2
Neurofibroma Research Study Groups: 0.5% NFX-179 gel, Vehicle gel, 1.5% NFX-179 gel
Neurofibroma Clinical Trial 2023: NFX-179 gel Highlights & Side Effects. Trial Name: NCT05005845 — Phase 2
NFX-179 gel (Topical Gel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005845 — Phase 2
Neurofibroma Patient Testimony for trial: Trial Name: NCT05005845 — Phase 2
~50 spots leftby Oct 2025