NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
RE
Overseen ByRoy E Strowd, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: NFlection Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
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
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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.
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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?
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
NFlection Therapeutics, Inc.
Lead Sponsor
Trials
3
Recruited
250+
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