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

Not Recruiting

Trial ID: NCT05195762


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
Albert Sean Chiou, MD, MBA

Clinical Associate Professor, Dermatology


Inclusion Criteria

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

   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

      - 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

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

   3. The Subject has used any of the following systemic medications in the noted time

      - 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

   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.


drug: NFX-179 Gel 1.50%

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Study Coordinator