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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02781311
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE May 24, 2016
Results First Submitted Date  ICMJE March 15, 2019
Results First Posted Date  ICMJE April 5, 2019
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE July 14, 2016
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Change From Baseline in Target Area Hair Count (TAHC) at Week 24 [ Time Frame: Baseline (Day 1) to Week 24 ]
    TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.
  • Subject Self-Assessment (SSA) Score in Hair Growth at Week 24 [ Time Frame: Week 24 ]
    The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • Change from Baseline in Target Area Hair Count (TAHC) within a 1 cm^2 Circular Area [ Time Frame: Baseline, Week 24 ]
  • Subject Self-Assessment (SSA) of the Change in Scalp Hair Growth using a 7-Point Scale [ Time Frame: Baseline, Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Official Title  ICMJE Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia
Intervention  ICMJE
  • Drug: Setipiprant
    Setipiprant tablets, orally, BID for 24 weeks.
    Other Names:
    • KYTH-105
    • AGN-241679
  • Drug: Placebo
    Placebo tablets, orally, BID for 24 weeks.
  • Drug: Finasteride
    Finasteride tablet, orally, once daily for 24 weeks.
Study Arms  ICMJE
  • Experimental: Setipiprant
    Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
    Intervention: Drug: Setipiprant
  • Placebo Comparator: Placebo
    Two placebo tablets BID at 12-hour intervals for 24 weeks.
    Intervention: Drug: Placebo
  • Active Comparator: Finasteride
    Finasteride 1 mg tablet, orally, once daily for 24 weeks.
    Intervention: Drug: Finasteride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2017)
169
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2016)
187
Actual Study Completion Date  ICMJE May 22, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Androgenetic Alopecia in Males
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02781311
Other Study ID Numbers  ICMJE 1922-201-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joan-En Lin Allergan
PRS Account Allergan
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP