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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males (NCT02781311)

This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).
  • Drug: setipiprant
    Two 500 mg setipiprant tablets BID.
    • KYTH-105
  • Drug: placebo
    Two placebo tablets BID.
    Ages eligible for Study
    18 Years to 49 Years
    Genders eligible for Study
    Male
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Participant has androgenetic alopecia (AGA)
    • Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.
    Exclusion Criteria:
    • History of hair loss for reasons other than AGA
    • Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
    • Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
    • Hair-weaving within 6 months
    • Use of hair colorants or dyes within 6 months.

    18 locations

    United States (18)
    • Burke Pharmaceutical Research
      Not specified
      Hot Springs, Arkansas, United States, 71913
    • Petrus Center for Aesthetic Surgery & Hair Transplantation
      Not specified
      Little Rock, Arkansas, United States, 72205
    • Therapeutics Clinical Research
      Not specified
      San Diego, California, United States, 92123
    • Synexus USA
      Not specified
      Santa Rosa, California, United States, 95405
    • Arano, LLC
      Not specified
      Chicago, Illinois, United States, 60611
    • Heartland Research Associates, LLC
      Not specified
      Wichita, Kansas, United States, 67207
    • Minnesota Clinical Study Center
      Not specified
      Fridley, Minnesota, United States, 55432
    • University of Minnesota
      Not specified
      Minneapolis, Minnesota, United States, 55455
    • Wake Forest University Health Sciences
      Not specified
      Winston-Salem, North Carolina, United States, 27157
    • Cleveland Clinic
      Not specified
      Cleveland, Ohio, United States, 44195
    • NW Dermatology & Research Center
      Not specified
      Portland, Oregon, United States, 97210
    • Oregon Medical Research Center
      Not specified
      Portland, Oregon, United States, 97223
    • Penn State Hershey Medical Center
      Not specified
      Hershey, Pennsylvania, United States, 17033
    • Synexus USA
      Not specified
      Greer, South Carolina, United States, 29650
    • DermResearch, Inc
      Not specified
      Austin, Texas, United States, 78759
    • Suzzane Bruce and Associates P.A., The Center for Skin Research
      Not specified
      Katy, Texas, United States, 77494
    • The Education & Research Foundation
      Not specified
      Lynchburg, Virginia, United States, 24501
    • Michigan Center for Skin Care Research
      Not specified
      Clinton Township, Michigan, United States, 48038
    Status:
    active not recruiting
    Type:
    Interventional
    Phase:
    Start:
    28 June, 2016
    Updated:
    03 April, 2018
    Participants:
    169
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