Phase 2A 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
Last Update Posted : December 18, 2018
|
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 15, 2018 |
| Actual Study Completion Date : | May 22, 2018 |
Resource links provided by the National Library of Medicine
| 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. |
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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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.
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
| 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 |
| 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 |
| Last Update Posted: | December 18, 2018 |
| Last Verified: | December 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 |