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Topical Gel
0.5% NFX-179 gel for Neurofibroma
Phase 2
Waitlist Available
Research Sponsored by NFlection Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 182 days
Summary
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.
Eligible Conditions
- Neurofibromas
- Neurofibromatosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 182 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~182 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and effectiveness of once daily NFX-179 gel treatment for 182 days measured by local tolerability assessments, safety laboratory tests, and target cNF volume reduction
Safety of once daily NFX-179 gel treatment for 182 days by adverse events and serious adverse events assessments
Secondary study objectives
Percent change in cNF volume over 182 days
Percent of subjects with at least 50% Target cNF volume reduction after 182 days
Physician's Tumor Assessment of Target cNF severity over 182 days
+1 moreOther study objectives
Patient Reported Outcome Measure to assess Target cNF symptoms over 182 days
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: 0.5% NFX-179 gelActive Control1 Intervention
Topical gel applied once daily to target cNFs
Group II: 1.5% NFX-179 gelActive Control1 Intervention
Topical gel applied once daily to target cNFs
Group III: Vehicle gelPlacebo Group1 Intervention
Topical gel applied once daily to target cNFs
Who is running the clinical trial?
NFlection Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Neurofibroma
48 Patients Enrolled for Neurofibroma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at least 18 years of age.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.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.You have used imiquimod within the last 30 days.You have taken MEK inhibitors within the last 180 days.You have taken BRAF inhibitors within the past 180 days.You have been diagnosed with NF1 by a healthcare professional.You do not currently have a skin infection.I'm sorry but this is not a screening criterion for a clinical trial. This statement is incomplete and does not have enough context for me to understand what it refers to.You have undergone LASER, light treatments (like intense pulsed light or photo-dynamic therapy), or other energy-based therapies within the past 180 days.You have taken MEK inhibitor or BRAF inhibitor medications at any time in the past.You have physical characteristics and symptoms that match the usual signs of the condition being studied.You have had an allergic reaction to any of the ingredients in the study medications.You have a type of skin growth called a cNF that is separate from the surrounding healthy skin and can be clearly seen by the doctor.You do not have any signs of irritation, such as bleeding or inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: 0.5% NFX-179 gel
- Group 2: Vehicle gel
- Group 3: 1.5% NFX-179 gel
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Neurofibroma Patient Testimony for trial: Trial Name: NCT05005845 — Phase 2
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