Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Study Description

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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	Phase 2

Study Design

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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 :	June 29, 2016
Actual Primary Completion Date :	March 13, 2018
Estimated Study Completion Date :	May 21, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Setipiprant; 1000 mg setipiprant (two 500 mg tablets) twice daily (BID) at 12-hour intervals for 24 weeks.	Drug: setipiprant; Two 500 mg setipiprant tablets BID.; Other Name: KYTH-105
Placebo Comparator: Placebo; Two placebo tablets BID at 12-hour intervals for 24 weeks.	Drug: placebo; Two placebo tablets BID.

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline in Target Area Hair Count (TAHC) within a 1 cm^2 Circular Area [ Time Frame: Baseline, Week 24 ]
2. Subject Self-Assessment (SSA) of the Change in Scalp Hair Growth using a 7-Point Scale [ Time Frame: Baseline, Week 24 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes Eligible for Study:	Male
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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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
Synexus USA
Santa Rosa, California, United States, 95405
United States, Illinois
Arano, LLC
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
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
NW Dermatology & Research Center
Portland, Oregon, United States, 97210
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Synexus USA
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
Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Allergan

Investigators

Study Director:	Joan-En Lin	Allergan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT02781311 History of Changes
Other Study ID Numbers:	1922-201-002
First Posted:	May 24, 2016
Last Update Posted:	May 14, 2018
Last Verified:	May 2018

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

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis	Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical