12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi
Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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