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

Alopecia Clinical Trial

Official title:

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781311
• Other study ID #: 1922-201-002
• Status: Completed
• Phase: Phase 2
• Start date: July 14, 2016
• Est. completion date: May 22, 2018

Study information

• Verified date: March 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 22, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Setipiprant
Setipiprant tablets, orally, BID for 24 weeks.
• Placebo
Placebo tablets, orally, BID for 24 weeks.
• Finasteride
Finasteride tablet, orally, once daily for 24 weeks.

Locations

Country	Name	City	State
United States	DermResearch, Inc	Austin	Texas
United States	DeNova Research	Chicago	Illinois
United States	Cleveland Clinic, Dept of Dermatology	Cleveland	Ohio
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Penn State Hershey Medical Center Dermatology Research Office	Hershey	Pennsylvania
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Suzzane Bruce and Associates P.A., The Center for Skin Research	Katy	Texas
United States	Petrus Center for Aesthetic Surgery & Hair Transplantation	Little Rock	Arkansas
United States	The Education & Research Foundation, Inc	Lynchburg	Virginia
United States	University of Minnesota Department of Dermatology Division of Clinical research	Minneapolis	Minnesota
United States	NW Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Therapeutics Clinical Research	San Diego	California
United States	Radiant Research, Inc.	Santa Rosa	California
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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