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12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi

NCT05195762 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-28

No results posted yet for this study

Summary

This study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. NFX-179 has been shown in animal studies and in human extracts to suppress p-ERK with systemic absorption of NFX-179 following topical application to be extremely low, based on serum values observed in animal studies.

Primary objectives:

* To determine the pharmacodynamic activity of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target EN in treatment group after 12 weeks of once-daily (QD) application
* To determine the safety and tolerability of treatment with NFX-179 Gel 1.50% applied QD for 12 weeks.

Secondary objectives:

-Clinical effect of NFX-179 Gel 1.5% defined as the percent change in EN volume after 12 weeks of QD application

Conditions

  • Epidermal Nevi
  • Nevus Sebaceus

Interventions

DRUG

NFX-179 Gel 1.50%

Stanford University (Stanford) is studying a selective mitogen-activated protein kinase kinase (MEK) inhibitor (NFX-179) that has been chemically engineered for topical application to treat epidermal nevus syndromes (ENS). Preclinical studies evaluating topical application of NFX-179 to human nevus sebaceous explants demonstrated that NFX-179 can penetrate the tissue and suppress the p-ERK biomarker. It was also determined that NFX-179, when incubated with the tissues in medium, also suppressed ERK phosphorylation in human keratinocytic epidermal nevi. This clinical study is designed to evaluate the safety, tolerability, and clinical effect of NFX-179 Gel in Subjects with Epidermal Nevi.

Sponsors & Collaborators

  • NFlection Therapeutics, Inc.

    collaborator INDUSTRY

  • Albert Chiou

    lead OTHER

Principal Investigators

  • Albert S Chiou, MD, MBA · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05195762 on ClinicalTrials.gov