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

Allergan

Status and phase: Completed; Phase 2

Conditions: Alopecia

Treatments: Drug: Placebo; Drug: Setipiprant; Drug: Finasteride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02781311

1922-201-002

Details and patient eligibility

About

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).

Enrollment: 169 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 3 patient groups, including a placebo group

Setipiprant

Experimental group

Description:

Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.

Treatment:

Drug: Setipiprant

Placebo

Placebo Comparator group

Description:

Two placebo tablets BID at 12-hour intervals for 24 weeks.

Treatment:

Drug: Placebo

Finasteride

Active Comparator group

Description:

Finasteride 1 mg tablet, orally, once daily for 24 weeks.

Treatment:

Drug: Finasteride