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12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi
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
Details
| Lead sponsor | Albert Chiou |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2023-06 |
| Completion | 2024-12 |
Conditions
- Epidermal Nevi
- Nevus Sebaceus
Interventions
- NFX-179 Gel 1.50%
Primary outcomes
- The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion — 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment. - The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0 — 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
Countries
United States