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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NEOSH101 2% |
|
| 2 | Experimental | NEOSH101 1% |
|
| 3 | Experimental | NEOSH101 0.5% |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tetrapeptide aldehyde proteasome inhibitor (NEOSH101) | Drug | Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Gassmueller, MD | bioskin Institute for Dermatological Research and Development GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| bioskin Institute for Dermatological Research and Development GmbH | Hamburg | 20095 | Germany |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |