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Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
This study is currently recruiting participants.
Verified July 2017 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02781311
First received: May 20, 2016
Last updated: July 18, 2017
Last verified: July 2017
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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 in 18 to 49 years old males with androgenetic alopecia (AGA).
| Condition | Intervention | Phase |
|---|---|---|
| Alopecia | Drug: setipiprant Drug: placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
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 ]
- Subject Self-Assessment (SSA) of the Change in Scalp Hair Growth using a 7-Point Scale [ Time Frame: Baseline, Week 24 ]
| Estimated Enrollment: | 163 |
| Actual Study Start Date: | June 29, 2016 |
| Estimated Study Completion Date: | August 30, 2018 |
| Estimated Primary Completion Date: | June 30, 2018 (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.
|
Eligibility| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781311
Contacts
| Contact: Clinical Trials Registry Team | 1-877-277-8566 | 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 | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Therapeutics Clinical Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Radiant Research, Inc. | Recruiting |
| Santa Rosa, California, United States, 95405 | |
| United States, Florida | |
| Ameriderm Research | Withdrawn |
| Ormond Beach, Florida, United States, 32174 | |
| United States, Illinois | |
| DeNova Research | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| DuPage Medical Group | Withdrawn |
| Naperville, Illinois, United States, 60563 | |
| United States, Kansas | |
| Heartland Research Associates, LLC | Recruiting |
| Wichita, Kansas, United States, 67207 | |
| United States, Michigan | |
| Michigan Center for Skin Care Research | Recruiting |
| Clinton, Michigan, United States, 48038 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | Recruiting |
| Fridley, Minnesota, United States, 55432 | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| NW Dermatology & Research Center | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Oregon Medical Research Center | Recruiting |
| Portland, Oregon, United States, 97223 | |
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Carolina | |
| Radiant Research, Inc. | Recruiting |
| Greer, South Carolina, United States, 29650 | |
| United States, Texas | |
| DermResearch, Inc | Recruiting |
| Austin, Texas, United States, 78759 | |
| J&S Studies, Inc | Withdrawn |
| College Station, Texas, United States, 77845 | |
| Suzzane Bruce and Associates P.A., The Center for Skin Research | Recruiting |
| Katy, Texas, United States, 77494 | |
| United States, Virginia | |
| The Education & Research Foundation | Recruiting |
| Lynchburg, Virginia, United States, 24501 | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Gurpreet Ahluwalia | 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: | July 18, 2017 |
| 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 |
ClinicalTrials.gov processed this record on September 21, 2017