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Brief Title: NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Phase 2 Dose-Response Study to Determine Safety and Effectiveness of Two Concentrations of NFX-179 Gel in Subjects With Cutaneous Neurofibromas
Study ID: NCT05005845
Brief 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 subjects with cutaneous neurofibromas. At Visit 1, the investigator will identify 10 Target cNFs that fulfil the enrollment criteria. The Target cNFs must be located on the subject'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 QD to the Target cNFs for 182days (26 weeks). During the duration of the study subjects will be evaluated for safety and efficacy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Northwest Arkansas Clinical Trials Center, PLLC, Rogers, Arkansas, United States
Center for Dermatology Clinical Research, Inc., Fremont, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
University Clinical Trials, Inc., San Diego, California, United States
Children's National Hospital, Washington, District of Columbia, United States
University of Florida, Gainesville, Florida, United States
Northshore University HealthSystem, Evanston, Illinois, United States
Dawes Fretzin Clinical Research Group, Indianapolis, Indiana, United States
The Johns Hopkins School of Medicine, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Minnesota Clinical Study Center, New Brighton, Minnesota, United States
Skin Specialists, P.C., Omaha, Nebraska, United States
Sadick Research Group, LLC, New York, New York, United States
Skin Search of Rochester, Inc., Rochester, New York, United States
Wake Forest School of Medicine, Winston-Salem, North Carolina, United States
Apex Clinical Research Center, LLC, Mayfield Heights, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Derm Dox Center for Dermatology, Sugarloaf, Pennsylvania, United States
Dermatology Treatment and Research Center, Dallas, Texas, United States
UTHealth McGovern Medical School, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
The Education & Research Foundation, Inc., Lynchburg, Virginia, United States