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Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

NCT ID: NCT00418730

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

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.

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

Group Type EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

2

Group Type ACTIVE_COMPARATOR

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

3

Group Type PLACEBO_COMPARATOR

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type DRUG

Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

Interventions

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tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

Intervention Type DRUG

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
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 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-AGA003

Identifier Type: -

Identifier Source: org_study_id