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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

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).

Condition or disease Intervention/treatment Phase
Alopecia Drug: Setipiprant Drug: Placebo Drug: Finasteride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride

Arm Intervention/treatment
Experimental: Setipiprant
Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Drug: Setipiprant
Setipiprant tablets, orally, BID for 24 weeks.
Other Names:
  • KYTH-105
  • AGN-241679

Placebo Comparator: Placebo
Two placebo tablets BID at 12-hour intervals for 24 weeks.
Drug: Placebo
Placebo tablets, orally, BID for 24 weeks.

Active Comparator: Finasteride
Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Drug: Finasteride
Finasteride tablet, orally, once daily for 24 weeks.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Androgenetic Alopecia in Males
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781311


Locations
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United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Petrus Center for Aesthetic Surgery & Hair Transplantation
Little Rock, Arkansas, United States, 72205
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Radiant Research, Inc.
Santa Rosa, California, United States, 95405
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Michigan
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
University of Minnesota Department of Dermatology Division of Clinical research
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic, Dept of Dermatology
Cleveland, Ohio, United States, 44195
United States, Oregon
NW Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Pennsylvania
Penn State Hershey Medical Center Dermatology Research Office
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
Suzzane Bruce and Associates P.A., The Center for Skin Research
Katy, Texas, United States, 77494
United States, Virginia
The Education & Research Foundation, Inc
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joan-En Lin Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] February 17, 2017
Statistical Analysis Plan  [PDF] July 25, 2018


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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02781311     History of Changes
Other Study ID Numbers: 1922-201-002
First Posted: May 24, 2016    Key Record Dates
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents