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 measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.

Official Title
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A Phase 2 Multicenter, Randomized, Placebo- and Comparator-Controlled, Double-Blind Parallel Group 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: Caucasian men, in general good health, aged 18-49 years Norwood/Hamilton grades III-IV, 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 start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start

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> | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days<br>|
| Active Comparator: 2<br> | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days<br>|
| Placebo Comparator: 3<br> | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)<br>* Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days<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 |  | Through Study Day 197 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment score of dermal tolerability |  | Through Study Day 197 | 
| Physician's global assessment score |  | Through Study Day 197 | 

 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