Phase 2
N=169
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT02781311 ↗Enrolled (actual)
169
Serious AEs
1.2%
Results posted
Apr 2019
Primary outcome: Primary: Change From Baseline in Target Area Hair Count (TAHC) at Week 24 — 6.7; 7.1 terminal hairs/cm^2 — p=0.9239
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Setipiprant (Drug); Placebo (Drug); Finasteride (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Allergan
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Target Area Hair Count (TAHC) at Week 24 |
6.7; 7.1 | 0.9239 |
| PRIMARY Subject Self-Assessment (SSA) Score in Hair Growth at Week 24 |
-0.2; -0.3 | 0.9101 |
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.
Data sourced from ClinicalTrials.gov (NCT02781311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.