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NCT05005845 · ClinicalTrials.gov registry record · Phase 2
NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
A Phase 2 study of Neurofibromatosis 1 and Cutaneous Neurofibroma, sponsored by NFlection Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT05005845: Completed Phase 2 study of Neurofibromatosis 1 and Cutaneous Neurofibroma, sponsored by NFlection Therapeutics.
NCT05005845 is a Phase 2 study of Neurofibromatosis 1 and Cutaneous Neurofibroma that has completed, run by NFlection Therapeutics. The registered enrollment target is 199 participants, below the 1,027-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005845, a Phase 2 study of Neurofibromatosis 1 and Cutaneous Neurofibroma, has completed, sponsored by NFlection Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an event that occurred or worsened on or after the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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 |
What the finished NCT05005845 record still lists
NCT05005845 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 1,027-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (81% lower).
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.
NCT05005845 names 20 study sites across 16 states, led by California, Arkansas, New York.
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.
What interventions are being tested in trial NCT05005845?
The interventions under investigation include: Vehicle gel (DRUG), NFX-179 gel (DRUG).
Who is sponsoring clinical trial NCT05005845?
This trial is sponsored by NFlection Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05005845's enrollment target sits among peer trials
199 9th of 24 higher than 16 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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