Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

May 16, 2008 updated by: Neosil, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20095
        • bioskin Institute for Dermatological Research and Development GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
EXPERIMENTAL: 1
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
PLACEBO_COMPARATOR: 3
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hair density, hair growth rate, hair diameter as measured using the TrichoScan method
Time Frame: Through Study Day 197
Through Study Day 197

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neosil, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (ESTIMATE)

January 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 16, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOSH101-CLIN-AGA003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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