A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Phase 2

Completed

• Conditions: Alopecia
• Interventions: Drug: Placebo; Drug: Setipiprant; Drug: Finasteride

• Registration Number: NCT02781311
• Lead Sponsor: Allergan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Study Start: 2016-07-14
• Primary Completion: 2018-03-15
• Study Completion: 2018-05-22
• Status Verified: 2019-03
• Results First Submitted: 2019-03-15
• Results First Submitted QC: 2019-03-15
• Last Update Submitted: 2019-03-15
• Results First Posted: 2019-04-05
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two placebo tablets BID at 12-hour intervals for 24 weeks.
Setipiprant	Setipiprant	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Finasteride	Finasteride	Finasteride 1 mg tablet, orally, once daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Target Area Hair Count (TAHC) at Week 24	Baseline (Day 1) to 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.
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	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.

Trial Locations

Locations (17)

DeNova Research; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic, Dept of Dermatology; 🇺🇸 Cleveland, Ohio, United States

Heartland Research Associates, LLC; 🇺🇸 Wichita, Kansas, United States

DermResearch, Inc; 🇺🇸 Austin, Texas, United States

Penn State Hershey Medical Center Dermatology Research Office; 🇺🇸 Hershey, Pennsylvania, United States

Michigan Center for Skin Care Research; 🇺🇸 Clinton Township, Michigan, United States

Suzzane Bruce and Associates P.A., The Center for Skin Research; 🇺🇸 Katy, Texas, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Petrus Center for Aesthetic Surgery & Hair Transplantation; 🇺🇸 Little Rock, Arkansas, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

University of Minnesota Department of Dermatology Division of Clinical research; 🇺🇸 Minneapolis, Minnesota, United States

Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard; 🇺🇸 Winston-Salem, North Carolina, United States

NW Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Oregon Medical Research Center; 🇺🇸 Portland, Oregon, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Radiant Research, Inc.; 🇺🇸 Greer, South Carolina, United States

The Education & Research Foundation, Inc; 🇺🇸 Lynchburg, Virginia, United States