A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
NCT ID: NCT02781311
Last Updated: 2019-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2016-07-14
2018-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Setipiprant
Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Setipiprant
Setipiprant tablets, orally, BID for 24 weeks.
Placebo
Two placebo tablets BID at 12-hour intervals for 24 weeks.
Placebo
Placebo tablets, orally, BID for 24 weeks.
Finasteride
Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Finasteride
Finasteride tablet, orally, once daily for 24 weeks.
Interventions
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Setipiprant
Setipiprant tablets, orally, BID for 24 weeks.
Placebo
Placebo tablets, orally, BID for 24 weeks.
Finasteride
Finasteride tablet, orally, once daily for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
MALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Joan-En Lin
Role: STUDY_DIRECTOR
Allergan
Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Petrus Center for Aesthetic Surgery & Hair Transplantation
Little Rock, Arkansas, United States
Therapeutics Clinical Research
San Diego, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
DeNova Research
Chicago, Illinois, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
University of Minnesota Department of Dermatology Division of Clinical research
Minneapolis, Minnesota, United States
Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
Winston-Salem, North Carolina, United States
Cleveland Clinic, Dept of Dermatology
Cleveland, Ohio, United States
NW Dermatology and Research Center
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Penn State Hershey Medical Center Dermatology Research Office
Hershey, Pennsylvania, United States
Radiant Research, Inc.
Greer, South Carolina, United States
DermResearch, Inc
Austin, Texas, United States
Suzzane Bruce and Associates P.A., The Center for Skin Research
Katy, Texas, United States
The Education & Research Foundation, Inc
Lynchburg, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1922-201-002
Identifier Type: -
Identifier Source: org_study_id
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