NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)

Overseen By Roy E Strowd, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NFlection Therapeutics, Inc.

Must not be taking: Retinoids, MEK inhibitors, BRAF inhibitors

Disqualifiers: Liver disease, Metastatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 26 weeks

199 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicated gel called NFX-179 on people with benign skin tumors known as cutaneous neurofibromas. The gel is applied to the skin to help reduce the size or appearance of these tumors.

Are You a Good Fit for This Trial?

Inclusion Criteria

The growth being studied is not attached to a stem or stalk.

You do not have any abnormalities within 1 cm of your eye socket.

Is not covered with hair that might, in the investigator's opinion, interfere with obtaining photographs or impair evaluation of the cNF

Exclusion Criteria

You have taken corticosteroids within the past 30 days.

You have taken prescription retinoid medications (like tazarotene, tretinoin, and adapalene) within the past 30 days.

You have taken fluorouracil within the past 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive NFX-179 Gel or vehicle gel applied topically once daily to target cNFs for 182 days

26 weeks

Multiple visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NFX-179 gel
• Vehicle gel

How Is the Trial Designed?

Group I: 0.5% NFX-179 gel Active Control 1 Intervention

Topical gel applied once daily to target cNFs

Group II: 1.5% NFX-179 gel Active Control 1 Intervention

Topical gel applied once daily to target cNFs

Group III: Vehicle gel Placebo Group 1 Intervention

Topical gel applied once daily to target cNFs

Who Is Running the Clinical Trial?

NFlection Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

250+