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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>NEOSH101 2% | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks<br>|
| Experimental: 2<br>NEOSH101 1% | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks<br>|
| Experimental: 3<br>NEOSH101 0.5% | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks<br>|
| Placebo Comparator: 4<br> | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss