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

Inclusion Criteria

In order to be eligible to participate in this study, all of the following criteria must be met:

Subject is at least 18 years of age
Subject must provide written informed consent prior to any study procedures

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
Subject is willing to have hair in the area surrounding the Target EN shaved, if necessary, to obtain photographs
Subject is willing to minimize exposure of the Target EN to natural or artificial ultraviolet radiation
Subject is willing to abstain from application of non-study topical prescription and over the counter medications to the Target EN during the study
Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study
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.
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:

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
The Target EN has ever been treated with a topical MEK inhibitor or a topical BRAF inhibitor

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
Subject has a history of hypersensitivity to any of the ingredients in the study medications
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
Subject has, in the Investigator's opinion, a clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis
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
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
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.