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Spots Global Cancer Trial Database for NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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