Purpose of Study

The purpose of this study is to test the safety and effectiveness of 2 concentrations of NFX-179 gel compared with placebo gel in reducing the appearance of cutaneous neurofibromas (cNFs) in subjects with Neurofibromatosis Type 1 (NF1).

The Study Drug

  • NFX-179 Gel
  • NFX-179 Gel is a topical, first-in-class, “soft” MEK inhibitor that is currently being evaluated in Phase 2 clinical trials in patients with neurofibromatosis type 1

The Study

  • At Visit 1, the study doctor assesses patient eligibility and identifies 10 cutaneous neurofibromas for treatment with study medication
  • 8 cutaneous neurofibromas must be on the patient's chest, abdomen, shoulders, arms or back of hands
  • The topical study medication will be applied once daily on the 10 cutaneous neurofibromas for 6 months
  • Patients who qualify may be reimbursed for time and travel

Study Expectations

  • There is NO cost to participate
  • Participation in the study will last approximately 6 months
  • The patient will apply the topical study medication once daily to the 10 cutaneous neurofibromas
  • Study doctor visits will occur at least 9 times over 6 months

Will Everyone Receive the Active Concentration of NFX-179 Topical Gel?

  • 1/3 patients will receive study medication with an active concentration of NFX-179 Gel (0.5%)
  • 1/3 patients will receive study medication with an active concentration of NFX-179 Gel (1.5%)
  • 1/3 of patients will receive study medication with placebo concentration of NFX-179 Gel (0.0%)
  • The study doctor and patient will not know which patient receives an active or placebo concentration of NFX-179
  • Active or placebo concentrations NFX-179 Gel are randomly selected

Study Patients Must Meet The Following Criteria

  • Ages 18+
  • Diagnosed with neurofibromatosis type 1
  • Have 10 clinically diagnosed cNFs
  • 2 cutaneous neurofibromas on face

Request to be Contacted

To see if you qualify for this investigational study, please fill out this form and we will send your contact information to the closest available investigational site. Someone will respond to you within 3 to 5 business days.

If you do not see a location near you, please select Contact Me if Site Opens Nearby from Study Location below on form. A member of NFlection Therapeutics, Inc. will contact you in 3 to 5 business days with additional information.

    Dawes Fretzin Clinical Research Group, LLC
    7910 North Shadeland Avenue
    Indianapolis, IN 46250

    Site Contact
    Name: Elissa O’Malley
    Email: EO'Malley@ecommunity.com
    Phone: 317-516-5030

    Center for Dermatology Clinical Research, Inc.
    2557 Mowry Avenue, Suite 21 & 25, Fremont, CA 94538

    Site Contact
    Name: Mele Tupou
    Email: melet@ctr4derm.com
    Phone: (510) 797-0140

    Minnesota Clinical Study Center
    119-14th Street, N.W., Suite 250, New Brighton, MN 55112

    Site Contact
    Name: Allie Horita
    Email: ahorita@associatedskincare.com
    Phone: 763-502-2900

    University Clinical Trials, Inc.
    7695 Cardinal Court, Suite 210, San Diego, CA 92123

    Site Contact
    Name: Carlos Vega
    Email: carlos@univct.com
    Phone: (858) 278-8470

    Derm Dox Center for Dermatology
    8 Brookhill Square South, Sugarloaf, PA 18249

    Site Contact
    Name: Dana Mauch
    Email: dmmresearch@comcast.net
    Phone: 717-439-6900

    Lovely Skin
    2802 Oak View Mall Drive, Omaha, NE 68144

    Site Contact
    Name: Kayleigh Koziol
    Email: Kayleigh@lovelyskin.com
    Phone: (402) 334-7546

    Skin Search of Rochester, Inc.
    100 White Spruce Boulevard, Rochester, NY 14623

    Site Contact
    Name: Denise Forster
    Email: dforster@dermrochester.com

    The Education & Research Foundation, Inc.
    2095 Langhorne Road, Lynchburg, VA 24501

    Site Contact
    Name: Jennifer Bowling
    Email: Jbowling@educationandresearch.com

    University of Texas McGovern Medical School
    6410 Fannin Street, Suite 1535
    Houston, TX 77030

    Site Contact
    Name: Donovan Calvert
    Email: Donovan.Calvert@uth.tmc.edu

    NorthShore University HealthSystem: Clinical Trials Center
    9933 Woods Drive, Suite 100
    Skokie, IL 60077

    Site Contact
    Name: Erendida Sanchez
    Email: esanchez@northshore.org, bdavid@northshore.org

    Children's Hospital Los Angeles
    4650 Sunset Blvd, Mailstop #82
    Los Angeles, CA 90027

    Site Contact
    Name: Martha Arellano-Garcia
    Email: margarcia@chla.usc.edu

    University of Florida
    1505 SW Archer Rd 1st floor
    Gainesville, FL 32608

    Site Contact
    Name: Jessica Spana
    Email: Jessica.Spana@neurology.ufl.edu

    UAMS WPRCI
    4301 W. Markham St., #724
    Little Rock, AR 72205-7199

    Site Contact
    Name: Erika Santos Horta, MD
    Email: esantoshorta@uams.edu

    Massachusetts General Hospital
    55 Fruit Street
    Boston, MA 02114

    Site Contact
    Name: Chris O'Mara
    Email: comara@nflectionrx.com

    Site Activation Pending

    Wake Forest School of Medicine
    1 Medical Center Boulevard
    Winston Salem, NC 27157

    Site Contact
    Name: Gait Jordan
    Email: pgjordan@wakehealth.edu

    University of Utah, Division of Medical Genetics
    417 Wakara Way Suite 3209
    Salt Lake City, UT 84108

    Site Contact
    Name: Carrie Bailey
    Email: Carrie.Bailey@hsc.utah.edu

    Northwest Arkansas Clinical Trials Center, PLLC
    597 Horsebarn Road
    Rogers, AR 72758

    Site Contact
    Name: Hillary Hull
    Email: hillaryhullderm@yahoo.com

    Apex Clinical Research Center, LLC
    5800 Landerbrook Drive Suite 100
    Mayfield Heights, OH 44124

    Site Contact
    Name: Veronica Peck
    Email: vpeck@apexskin.com
    Phone: 216-262-2777

    Dermatology Treatment and Research Center
    5310 Harvest Hill Rd. Suite 160
    Dallas, TX 75230

    Site Contact
    Name: Nicole Luks
    Email: nluks@dermcaremgt.com
    Phone: 972-661-2729

    Don't see a site near you?

    A member of NFlection Therapeutics, Inc. will contact you in 3 to 5 business days with additional information.

    About NFX-179 Gel

    NFX-179 is an investigational mitogen-activated protein kinase kinase (MEK) inhibitor. NFX-179 is a “soft" (metabolically labile) drug, which, when formulated as NFX-179 Gel for topical application, is designed to concentrate at the dermal site of action but degrade in systemic circulation, thereby potentially significantly reducing side effects compared to systemically available MEK inhibitors.

    NFlection Therapeutics, Inc. has recently completed a successful Phase 2 study. Read more here.

    About Cutaneous
    Neurofibromatosis Type 1

    Cutaneous neurofibromas are tumors that grow from small nerves in the skin or just under the skin and appear as small or larger bumps typically beginning around the time of puberty. Individuals with neurofibromatosis type 1, commonly develop more cutaneous neurofibromas as they get older. They do not become malignant, but they may be disfiguring, itchy or painful when bumped. Despite their benign nature, they may cause significant problems (e.g., depression, isolation, etc.), and may require surgical removal.

    About NFlection
    Therapeutics, Inc.

    NFlection Therapeutics focuses on the discovery and development of effective, targeted therapies for rare disorders. NFlection is chiefly concerned with rare disorders known as RASopathies, which are driven by the aberrant activation of the Ras/Raf/MEK/ERK pathway. NFlection is working to address RASopathies through the development of first-in-class soft MEK (mitogen-activated protein kinase kinase) inhibitors as topical treatments to mitigate or treat cutaneous neurofibromas in neurofibromatosis type 1. NFlection's topical MEK inhibitors are designed to degrade rapidly in circulation to avoid systemic side effects. To learn more about the company, please visit www.nflectionrx.com.