Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Phase 2
- Conditions
- Androgenetic Alopecia
- Interventions
- Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
- Registration Number
- NCT00471510
- Lead Sponsor
- Neosil, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 140
Inclusion Criteria
- Men, aged 18 to 49 years, in general good health
- Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area
Exclusion Criteria
- Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tetrapeptide aldehyde proteasome inhibitor (NEOSH101) NEOSH101 2% 2 tetrapeptide aldehyde proteasome inhibitor (NEOSH101) NEOSH101 1% 3 tetrapeptide aldehyde proteasome inhibitor (NEOSH101) NEOSH101 0.5% 4 tetrapeptide aldehyde proteasome inhibitor (NEOSH101) -
- Primary Outcome Measures
Name Time Method Hair density, hair growth rate, hair diameter as measured using the Trichoscan method 16 weeks application treatment period followed by 12 weeks observation period
- Secondary Outcome Measures
Name Time Method Assessment score of dermal tolerability 16 weeks application treatment period followed by 12 weeks observation period Physician's global assessment score 16 weeks application treatment period followed by 12 weeks observation period
Trial Locations
- Locations (1)
bioskin Institute for Dermatological Research and Development GmbH
🇩🇪Hamburg, Germany