STUDY OF SETIPIPRANT TABLETS IN ANDROGENETIC ALOPECIA IN MALES WITH A COMPARATOR ARM

What we are studying

Structure: Multicenter, randomized, double-blind, placebo-controlled study designed to determine the effect of treatment with setipiprant tablets 1000 mg BID on scalp hair growth. Duration: Approximately 32 weeks (enrollment through exit) Study Treatment Group: Setipiprant tablets 1000 mg BID Control: Placebo BID and finasteride 1 mg once daily Dosage/Dose Regimen: Setipiprant tablets 1000 mg BID, placebo tablets BID, or finasteride 1 mg once daily taken orally for 24 weeks Enrollment/Stratification: Eligible non-PK subjects will be randomly assigned to 1 of 3 treament groups in a 2:2:1 ratio to receive setipiprant tablets 1000 mg BID, placebo BID, or finasteride 1 mg once daily. PK subjects will be randomly assigned to 1 of 2 treatment groups in a 5:1 ratio, setipiprant tablets 1000 mg BID or placebo BID. Non-PK subjects will be stratified by baseline age, 18 to 34 and 35 to 41 years. Visit Schedule: Seven scheduled study visits (screening [Days ?28 to ?1], Day 1 [baseline], Weeks 4, 8, 16, 24 [treatment period], and Week 32 or early exit visit [follow-up]).

Who we are studying

  • Men
  • Races:
    • White
    • African American
  • Not Hispanic or Latino
  • Ages 18 - 41

Eligibility Criteria

  • Must have androgenetic alopecia

What is involved

  • Photography six visits
  • Vital signs and height 7 visits
  • Physical exam 3 visits
  • Microdot tattoo 1 visit
  • Subject assessments 6 visits
  • ECG 4 visits
  • Lab draws 6 visits
  • Urine drug screen 1 visit

Compensation

$50 for Each Completed Visit or a Total of $350

Contact Information

Study Coordinator
Dermatology Clinical Studies
Email
dermadvertising@wakehealth.edu
Phone
336-716-3775
Principal Investigator
Amy McMichael, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.