A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Last updated: March 15, 2019
Sponsor: Allergan
Overall Status: Completed

Phase

2

Condition

Hair Loss

Alopecia

Treatment

N/A

Clinical Study ID

NCT02781311
1922-201-002
  • Ages 18-49
  • Male

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has androgenetic alopecia (AGA)

  • Participant agrees to maintain current hair care regimen, refraining from hairweaving, hair colorants or dyes and non-study hair growth products during the study.

Exclusion

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 monththat could impact hair growth

  • Hair-weaving within 6 months

  • Use of hair colorants or dyes within 6 months.

Study Design

Total Participants: 169
Study Start date:
July 14, 2016
Estimated Completion Date:
May 22, 2018

Connect with a study center

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Petrus Center for Aesthetic Surgery & Hair Transplantation

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • Radiant Research, Inc.

    Santa Rosa, California 95405
    United States

    Site Not Available

  • Ameriderm Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • DeNova Research

    Chicago, Illinois 60611
    United States

    Site Not Available

  • DuPage Medical Group

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Michigan Center for Skin Care Research

    Clinton, Michigan 48038
    United States

    Site Not Available

  • Michigan Center for Skin Care Research

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Michigan Center for Skin Care Research

    ClintonTownship, Michigan 48038
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • University of Minnesota Department of Dermatology Division of Clinical research

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cleveland Clinic, Dept of Dermatology

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • NW Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Penn State Hershey Medical Center Dermatology Research Office

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Radiant Research, Inc.

    Greer, South Carolina 29650
    United States

    Site Not Available

  • DermResearch, Inc

    Austin, Texas 78759
    United States

    Site Not Available

  • J&S Studies, Inc

    College Station, Texas 77845
    United States

    Site Not Available

  • Suzzane Bruce and Associates P.A., The Center for Skin Research

    Katy, Texas 77494
    United States

    Site Not Available

  • The Education & Research Foundation, Inc

    Lynchburg, Virginia 24501
    United States

    Site Not Available

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