What is the mechanism of action of this treatment?

Common treatments for moles, particularly those targeting pathways similar to NFX-179 Gel, often focus on inhibiting cellular signaling pathways that promote abnormal cell growth. NFX-179 Gel works by suppressing phospho-ERK (p-ERK) levels, a key player in the MAPK/ERK pathway, which is involved in cell proliferation and survival. By reducing p-ERK levels, NFX-179 Gel can potentially decrease the growth of epidermal nevi. This is significant for mole patients as it offers a targeted approach to manage and reduce mole size and proliferation, potentially improving cosmetic outcomes and reducing the risk of malignant transformation.

What side effects are associated with this type of intervention?

Common treatments for moles include surgical excision, laser therapy, and topical treatments. Surgical excision can lead to scarring and infection. Laser therapy may cause temporary redness, swelling, and changes in skin pigmentation. Topical treatments, such as those similar to NFX-179 Gel, which aim to suppress specific molecular pathways like phospho-ERK (p-ERK), generally have low systemic absorption but can cause local skin irritation, redness, and dryness. It is important to discuss potential side effects with a healthcare provider to choose the most appropriate treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for moles that directly target the suppression of phospho-ERK (p-ERK) levels. However, drugs like selumetinib, a MEK1/2 inhibitor, have been approved for conditions involving similar pathways, such as neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas. These treatments work by inhibiting the MEK/ERK pathway, which is involved in cell growth and differentiation, similar to the mechanism being studied with NFX-179 Gel.

What other types of research exist?

A promising alternative to NFX-179 Gel for the suppression of phospho-ERK (p-ERK) levels in mole patients is Selumetinib, an oral MEK inhibitor. Selumetinib has demonstrated efficacy in conditions involving the MAPK/ERK pathway, such as neurofibromatosis type 1-related plexiform neurofibromas. Other MEK inhibitors may also be considered as potential alternatives.

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NFX-179 Gel for Epidermal Nevus

Phase 2

Waitlist Available

Led By Albert S Chiou, MD, MBA

Research Sponsored by Albert Chiou

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study

Must not have

Systemic retinoids (e.g., etretinate, isotretinoin) in the previous 90 days

Fluorouracil

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a skin gel called NFX-179 on patients with a skin condition called Epidermal Nevus. The gel aims to reduce a protein in the skin that is associated with this condition. The study will check if the gel is safe and effective over a few months.

Who is the study for?

Adults with a specific skin condition called Epidermal Nevi, who have lesions of a certain size and severity, can join this trial. They must not use other skin treatments during the study and should be able to apply the gel themselves. Women must test negative for pregnancy and agree to use contraception. People with recent cancer, liver disease, or those on certain medications cannot participate.

What is being tested?

The trial is testing NFX-179 Gel's ability to reduce activity in a pathway linked to Epidermal Nevi growth (p-ERK levels) after daily application for 12 weeks. It also looks at safety, tolerability, and how well it reduces lesion volume.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include local skin reactions like redness or irritation where the gel is applied due to its active ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin condition has been confirmed by a biopsy.

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I agree not to seek other treatments for my condition outside of the study.

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I do not have any skin infections.

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My lesion is isolated with healthy skin around it.

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I have never had surgery for my condition.

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I am a woman who can have children, not pregnant, and willing to use birth control during the study.

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My affected area is 100cm2 or smaller.

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I can reach the area where I need to apply the medication.

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I am 18 years old or older.

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I am willing to not use any non-study skin medications during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken any retinoid medications in the last 90 days.

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I am currently taking or have taken Fluorouracil.

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I have used topical MEK or BRAF inhibitors for my condition.

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I haven't taken MEK inhibitors in the last 6 months.

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I am using steroid creams or ointments.

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I am using a cream or gel for my skin condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0

The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion

Secondary study objectives

Change in ILA (Investigator's Lesion Assessment)

Percent change in EN volume

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients receiving NFX-179 GelExperimental Treatment1 Intervention

NFX-179 Gel 1.50% applied QD for 12 weeks

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for moles, particularly those targeting pathways similar to NFX-179 Gel, often focus on inhibiting cellular signaling pathways that promote abnormal cell growth. NFX-179 Gel works by suppressing phospho-ERK (p-ERK) levels, a key player in the MAPK/ERK pathway, which is involved in cell proliferation and survival. By reducing p-ERK levels, NFX-179 Gel can potentially decrease the growth of epidermal nevi. This is significant for mole patients as it offers a targeted approach to manage and reduce mole size and proliferation, potentially improving cosmetic outcomes and reducing the risk of malignant transformation.

Early Treatment Initiation Improves Outcomes in Nevus of Ota: A 10-Year Retrospective Study.Clinical Evidence of Cell-Targeted Topical Therapy for Treating Skin Dyspigmentation.Efficacy of narrow-band ultraviolet-B therapy in patch-stage mycosis fungoides: A clinical study and review of the literature.