A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
1 other identifier
interventional
169
1 country
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2016
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedStudy Start
First participant enrolled
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2018
CompletedResults Posted
Study results publicly available
April 5, 2019
CompletedApril 5, 2019
March 1, 2019
1.7 years
May 20, 2016
March 15, 2019
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Target Area Hair Count (TAHC) at Week 24
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm\^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm\^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.
Baseline (Day 1) to Week 24
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.
Week 24
Study Arms (3)
Setipiprant
EXPERIMENTALSetipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Placebo
PLACEBO COMPARATORTwo placebo tablets BID at 12-hour intervals for 24 weeks.
Finasteride
ACTIVE COMPARATORFinasteride 1 mg tablet, orally, once daily for 24 weeks.
Interventions
Setipiprant tablets, orally, BID for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (18)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Petrus Center for Aesthetic Surgery & Hair Transplantation
Little Rock, Arkansas, 72205, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Radiant Research, Inc.
Santa Rosa, California, 95405, United States
DeNova Research
Chicago, Illinois, 60611, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
University of Minnesota Department of Dermatology Division of Clinical research
Minneapolis, Minnesota, 55455, United States
Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic, Dept of Dermatology
Cleveland, Ohio, 44195, United States
NW Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Penn State Hershey Medical Center Dermatology Research Office
Hershey, Pennsylvania, 17033, United States
Radiant Research, Inc.
Greer, South Carolina, 29650, United States
DermResearch, Inc
Austin, Texas, 78759, United States
Suzzane Bruce and Associates P.A., The Center for Skin Research
Katy, Texas, 77494, United States
The Education & Research Foundation, Inc
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to change in planned analysis, data of participants in the finasteride arm group were not included in the efficacy analysis.
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Joan-En Lin
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 24, 2016
Study Start
July 14, 2016
Primary Completion
March 15, 2018
Study Completion
May 22, 2018
Last Updated
April 5, 2019
Results First Posted
April 5, 2019
Record last verified: 2019-03