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NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
NCT05005845 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 gel in participants with cNF. At Visit 1 (Screening visit), the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the participant's face, anterior trunk, or upper extremities. Two Target cNFs must be on the face and 8 must be on the anterior trunk or upper extremities. The study medication will be applied topically once daily to the Target cNFs for 182 days (26 weeks). During the duration of the study participants will be evaluated for safety and efficacy.
Conditions Studied
Interventions
- DRUG Vehicle gel
- DRUG NFX-179 gel
Study Locations (20)
California
- Center for Dermatology Clinical Research, Inc. — Fremont
- Children's Hospital Los Angeles — Los Angeles
- University Clinical Trials, Inc. — San Diego
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
- Northwest Arkansas Clinical Trials Center, PLLC — Rogers
New York
- Sadick Research Group, LLC — New York
- Skin Search of Rochester, Inc. — Rochester
District of Columbia
- Children's National Hospital — Washington D.C.
Florida
- University of Florida — Gainesville
Illinois
- Northshore University HealthSystem — Evanston
Indiana
- Dawes Fretzin Clinical Research Group — Indianapolis
Maryland
- The Johns Hopkins School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05005845
The ClinicalTrials.gov registry entry for NCT05005845 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NFlection Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 2 interventions — of which Vehicle gel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05005845 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Arkansas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05005845 about?
NCT05005845 is a clinical study titled "NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)". This is a randomized, double-blind, vehicle-controlled, parallel group dose response study evaluating the safety and effectiveness of 2 concentrations of NFX-179 gel in participants with cNF. At Visit 1 (Screening visit), the investigator will identify 10 Target cNFs that fulfil the enrollment crite...
What is the current status of trial NCT05005845?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2021-09-29. Estimated completion is 2023-10-02.
What conditions does trial NCT05005845 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Cutaneous Neurofibroma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05005845?
The interventions under investigation include: Vehicle gel (DRUG), NFX-179 gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05005845?
This trial is sponsored by NFlection Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05005845 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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