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

This is an interventional treatment trial for Epidermal Nevi Read More

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.