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

NCT ID: NCT00471510

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

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.

Detailed Description

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Conditions

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Androgenetic Alopecia

Keywords

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androgenetic alopecia male pattern hair loss male pattern baldness androgenetic alopecia or male pattern hair loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

NEOSH101 2%

Group Type EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

2

NEOSH101 1%

Group Type EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

3

NEOSH101 0.5%

Group Type EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

4

Group Type PLACEBO_COMPARATOR

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Interventions

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tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Neosil, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Neosil, Inc.

Principal Investigators

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Johannes Gassmueller, MD

Role: PRINCIPAL_INVESTIGATOR

bioskin Institute for Dermatological Research and Development GmbH

Locations

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bioskin Institute for Dermatological Research and Development GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NEOSH101-CLIN-AGA004

Identifier Type: -

Identifier Source: org_study_id