©2022 Stanford Medicine
12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi
Not Recruiting
Trial ID: NCT05195762
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
Stanford Investigator(s)
Albert Sean Chiou, MD, MBA
Clinical Associate Professor, Dermatology
Eligibility
Inclusion Criteria
In order to be eligible to participate in this study, all of the following criteria must be
met:
1. Subject is at least 18 years of age
2. Subject must provide written informed consent prior to any study procedures
3. 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
4. Subject is willing to have hair in the area surrounding the Target EN shaved, if
necessary, to obtain photographs
5. Subject is willing to minimize exposure of the Target EN to natural or artificial
ultraviolet radiation
6. Subject is willing to abstain from application of non-study topical prescription and
over the counter medications to the Target EN during the study
7. Subject is willing to forego treatment of the Target EN, except protocol specified
therapy, during the study
8. 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.
9. 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:
1. 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)
- Fluorouracil
- Imiquimod
2. The Target EN has ever been treated with a topical MEK inhibitor or a topical BRAF
inhibitor
3. The Subject has used any of the following systemic medications in the noted time
period:
- Systemic retinoids (e.g., etretinate, isotretinoin) in the previous 90 days
- Systemic MEK inhibitors in the previous 180 days
- Systemic BRAF inhibitors in the previous 180 days
4. Subject has a history of hypersensitivity to any of the ingredients in the study
medications
5. Subject has any know intercurrent illness or physical condition that would, in the
investigator's opinion, impair evaluation of the Target EN or which exposes the
subject to an unacceptable risk by study participation
6. Subject has, in the Investigator's opinion, a clinically relevant history of liver
disease, including viral hepatitis, current alcohol abuse, or cirrhosis
7. Subject has a history of metastatic disease, or active cancer (excluding non-melanoma
skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage
0 chronic lymphocytic lymphoma) within the previous 5 years
8. Subject has any condition (e.g., other skin conditions or diseases, metabolic
dysfunction, physical examination findings, clinical laboratory findings) or situation
(e.g., vacation, scheduled surgery) that would, in the Investigator's opinion, impair
evaluation of the Target EN or which exposes the subject to an unacceptable risk by
study participation
9. Subject has participated in an investigational drug trial in which administration of
an investigational study medication occurred within the previous 30 days No waivers to
the exclusion criteria are permitted.
Intervention(s):
drug: NFX-179 Gel 1.50%
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Study Coordinator
650-206-0647