← Back to Search

Other

NFX-179 Gel for Epidermal Nevus

Phase 2
Waitlist Available
Led By Albert S Chiou, MD, MBA
Research Sponsored by Albert Chiou
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is a documented, biopsy proven, keratinocytic epidermal nevi (KEN) or nevus sebaceous (NS) or has a 3mm punch biopsy taken for histologic examination to determine KEN or NS status
Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing a new topical gel, NFX-179, to see if it is safe and effective in treating a skin condition called epidermal nevus syndrome. The gel is applied once daily for 12 weeks. The primary objective is to determine if the gel suppresses a protein called phospho-ERK in the skin. The secondary objective is to see if the gel reduces the size of epidermal nevi.

Who is the study for?
Adults with a specific skin condition called Epidermal Nevi, who have lesions of a certain size and severity, can join this trial. They must not use other skin treatments during the study and should be able to apply the gel themselves. Women must test negative for pregnancy and agree to use contraception. People with recent cancer, liver disease, or those on certain medications cannot participate.Check my eligibility
What is being tested?
The trial is testing NFX-179 Gel's ability to reduce activity in a pathway linked to Epidermal Nevi growth (p-ERK levels) after daily application for 12 weeks. It also looks at safety, tolerability, and how well it reduces lesion volume.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include local skin reactions like redness or irritation where the gel is applied due to its active ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin condition has been confirmed by a biopsy.
Select...
I agree not to seek other treatments for my condition outside of the study.
Select...
I do not have any skin infections.
Select...
My lesion is isolated with healthy skin around it.
Select...
I have never had surgery for my condition.
Select...
I am willing and able to follow the study's requirements and attend all visits.
Select...
I am a woman who can have children, not pregnant, and willing to use birth control during the study.
Select...
I have never had surgery for my condition.
Select...
I am willing to avoid sunlight and artificial UV light.
Select...
My affected area is 100cm2 or smaller.
Select...
I can reach the area where I need to apply the medication.
Select...
I am 18 years old or older.
Select...
I am willing to not use any non-study skin medications during the trial.
Select...
I have a specific skin condition targeted for treatment.
Select...
My lesion is isolated with healthy skin around it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
Secondary outcome measures
Change in ILA (Investigator's Lesion Assessment)
Percent change in EN volume

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients receiving NFX-179 GelExperimental Treatment1 Intervention
NFX-179 Gel 1.50% applied QD for 12 weeks

Find a Location

Who is running the clinical trial?

Albert ChiouLead Sponsor
NFlection Therapeutics, Inc.Industry Sponsor
2 Previous Clinical Trials
247 Total Patients Enrolled
Albert S Chiou, MD, MBAPrincipal InvestigatorStanford University

Media Library

NFX-179 Gel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05195762 — Phase 2
Mole Research Study Groups: Patients receiving NFX-179 Gel
Mole Clinical Trial 2023: NFX-179 Gel Highlights & Side Effects. Trial Name: NCT05195762 — Phase 2
NFX-179 Gel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195762 — Phase 2
Mole Patient Testimony for trial: Trial Name: NCT05195762 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the NFX-179 Gel 1.50% been approved by the Food and Drug Administration?

"Our evaluation of NFX-179 Gel 1.50%'s safety rate it a 2 out of 3, as this is still in Phase 2 trials and there are some indications that the drug has not been proven efficacious yet."

Answered by AI

Is enrollment for this research endeavor still open?

"The details provided on clinicaltrials.gov reveal that this trial is no longer actively recruiting patients; it was initially posted on June 1st 2023, and last edited October 25th 2022. Nevertheless, there are 7 other studies accepting enrollees at the present time."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Why haven't I heard about this on the news ?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have NF1. I'm interested in trial. I have NF not sure which one upon reading about the trials others are having with NFX-179 I decided to contact you I spoke with 3 Pharmacy only 1 was familiar with the term. So hopefully this can be a life changing endeavour.
PatientReceived 2+ prior treatments
~2 spots leftby Jun 2024