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

Trial ID or NCT#

NCT05195762

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Albert Sean Chiou, MD, MBA
Albert Sean Chiou, MD, MBA
Dermatologist, Cutaneous oncology specialist
Clinical Associate Professor, Dermatology

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Contact

Study Coordinator
650-206-0647