NCT00471510

Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Neosil, Inc. · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-02-01
• First posted: 2007-05-10
• Last updated: 2008-05-20

Locations

1 site across 1 country: Germany