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

Withdrawn before enrolling · Phase 2

Conditions studied: Epidermal Nevi, Nevus Sebaceus

In brief

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

Key facts

Study ID: NCT05195762
Run by: Albert Chiou
People needed: 0
Starts: 2023-06-01
Expected to finish: 2024-12-01
Last updated by the study team: 2024-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In order to be eligible to participate in this study, all of the following criteria must be met:
Subject is at least 18 years of age
Subject must provide written informed consent prior to any study procedures
Subject has a Target Epidermal Nevi for treatment that:
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
Is a discrete lesion surrounded with at least 5mm of non-involved skin
Is not irritated
Does not have an active cutaneous infection
Has a Length ≥15mm
Has a surface area ≤100cm2
Has an Investigator's Lesion Assessment grade ≥2
Is located at an anatomical site that the subject can reach to apply the study medication
Has never been surgically treated
Subject is willing to have hair in the area surrounding the Target EN shaved, if necessary, to obtain photographs
Subject is willing to minimize exposure of the Target EN to natural or artificial ultraviolet radiation
Subject is willing to abstain from application of non-study topical prescription and over the counter medications to the Target EN during the study
Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study
Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study.
Subject is willing and able to follow all study instructions and to attend all study visits.
No waivers to the inclusion criteria are permitted.
Exclusion Criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
Subject has applied any of the following topical products in the previous 30 days on or in proximity to the Target EN that, in the investigator's opinion, impairs evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation:
Topical glucocorticoid steroids
Topical retinoids (e.g., tazarotene, tretinoin, adapalene)
> 5% of an alpha-hydroxy acid (e.g., glycolic acid, lactic acid)

Where it is running

Stanford University — Redwood City, California, United States

Full record on ClinicalTrials.gov

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