12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi
- Conditions
- Epidermal NeviNevus Sebaceus
- Interventions
- Drug: NFX-179 Gel 1.50%
- Registration Number
- NCT05195762
- Lead Sponsor
- Albert Chiou
- Brief 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
- Detailed Description
This is a 12-week clinical study to determine safety, tolerability, and clinical effect of NFX-179 Gel 1.50% Gel in subjects with EN.
At Visit 1 (Screening), the Investigator will select 1 Target EN lesion for treatment that meet the inclusion criteria. A biopsy tissue sample of the Target EN will be taken for histological confirmation of an EN diagnosis if required, to assess p-ERK levels and for genetic testing.
Subjects will be seen at Visit 2 for management of the Visit 1 biopsy wounds.
At Visit 3 (Baseline) eligible subjects will be provided study medication and start the 12-week, QD treatment period. Target EN assessments will be collected.
Subjects will be seen for treatment period visits, Visits 4-7, when Target EN assessments will be collected.
At Visit 8, subjects will be seen for the final treatment period visit. Target EN assessments, a biopsy sample for genetic testing and p-ERK levels will be. Subjects will start a 4-week no-treatment follow-up period.
Subjects will be seen at Visit 9, for management of the Visit 8 biopsy wound.
At Visit 10 (end of study), subjects will be seen for the final study visit and will be discharged from the study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients receiving NFX-179 Gel NFX-179 Gel 1.50% NFX-179 Gel 1.50% applied QD for 12 weeks
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Change in ILA (Investigator's Lesion Assessment) 12 weeks Change in Investigator's Lesion Assessment after 12 weeks of QD application, assessed at screening, baseline, treatment period at week 2, 3, 4, and 8, and end of treatment at week 12.
Percent change in EN volume 12 weeks Percent change in EN volume after 12 weeks of QD application as determined based on EN size derived from ruler measurements, and/or digital images from standardized photography performed at screening, baseline, treatment period at week 2, 3, 4, and 8, and end of treatment at week 12.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Redwood City, California, United States