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

Study Identifier
1922-201-002
CT.gov Identifier
NCT02781311
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Hair Loss - Other
    • Study Drug
  • Setipiprant
  • Placebo
  • Finasteride
    • Phase
    Phase 2
    Sex
    Male
    Age
    18 - 49 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Burke Pharmaceutical Research
    Hot Springs, Arkansas, United States, 71913
    Status
    Not applicable
    Location
    Petrus Center for Aesthetic Surgery & Hair Transplantation
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Therapeutics Clinical Research
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Radiant Research, Inc.
    Santa Rosa, California, United States, 95405
    Status
    Not applicable
    Location
    DeNova Research
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
    Location
    Heartland Research Associates, LLC
    Wichita, Kansas, United States, 67207
    Status
    Not applicable
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