Clinical trial NCT02781311: A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-05-24
Enrollment: 169
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Target Area Hair Count (TAHC) at Week 24
timeFrame: Baseline (Day 1) to Week 24
measure: Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Petrus Center for Aesthetic Surgery & Hair Transplantation
state: Arkansas
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology Division of Clinical research
state: Minnesota
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic, Dept of Dermatology
state: Ohio
city: Portland
country: United States
facility: NW Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center Dermatology Research Office
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: Katy
country: United States
facility: Suzzane Bruce and Associates P.A., The Center for Skin Research
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc
state: Virginia
Study officials:
affiliation: Allergan
name: Joan-En Lin
role: STUDY_DIRECTOR
References: