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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02781311
First received: May 20, 2016
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo and active comparator, finasteride 1 mg once daily, in 18 to 41 years old males with androgenetic alopecia (AGA).

Condition Intervention Phase
Alopecia
Drug: setipiprant
Drug: placebo
Drug: finasteride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 With a Comparator Arm

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Target Area Hair Count (TAHC) within a 1 cm^2 Circular Area [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Subject Self-Assessment (SSA) of the Change in Scalp Hair Growth using a 7-Point Scale [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 187
Study Start Date: June 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Finasteride
1 mg finasteride tablet once daily for 24 weeks.
Drug: finasteride
Finasteride tablet once daily.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02781311

Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

Locations
United States, Arkansas
Burke Pharmaceutical Research Recruiting
Hot Springs, Arkansas, United States, 71913
Petrus Center for Aesthetic Surgery & Hair Transplantation Not yet recruiting
Little Rock, Arkansas, United States, 72205
United States, Florida
Ameriderm Research Recruiting
Ormond Beach, Florida, United States, 32174
United States, Illinois
DuPage Medical Group Recruiting
Naperville, Illinois, United States, 60563
United States, Michigan
Michigan Center for Skin Care Research Recruiting
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Wake Forest University Health Sciences Not yet recruiting
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
NW Dermatology & Research Center Not yet recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Penn State Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
United States, Texas
DermResearch, Inc Recruiting
Austin, Texas, United States, 78759
J&S Studies, Inc Not yet recruiting
College Station, Texas, United States, 77845
United States, Virginia
The Education & Research Foundation Recruiting
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Allergan
Investigators
Study Director: Suzie MacKinnon Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02781311     History of Changes
Other Study ID Numbers: 1922-201-002 
Study First Received: May 20, 2016
Last Updated: August 8, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2017