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

Primary Purpose

Androgenetic Alopecia

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

bioskin Institute for Dermatological Research and Development GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

NEOSH101 2%

NEOSH101 1%

NEOSH101 0.5%

Outcomes

Primary Outcome Measures

Hair density, hair growth rate, hair diameter as measured using the Trichoscan method

Secondary Outcome Measures

Assessment score of dermal tolerability

Physician's global assessment score

Full Information

NCT ID

NCT00471510

First Posted

May 8, 2007

Last Updated

May 16, 2008

Sponsor

Neosil, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00471510

Brief Title

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

Official Title

A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Neosil, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

NEOSH101 2%

Arm Title

Arm Type

Experimental

Arm Description

NEOSH101 1%

Arm Title

Arm Type

Experimental

Arm Description

NEOSH101 0.5%

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Description

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

Primary Outcome Measure Information:

Title

Hair density, hair growth rate, hair diameter as measured using the Trichoscan method

Time Frame

16 weeks application treatment period followed by 12 weeks observation period

Secondary Outcome Measure Information:

Title

Assessment score of dermal tolerability

Time Frame

16 weeks application treatment period followed by 12 weeks observation period

Title

Physician's global assessment score

Time Frame

16 weeks application treatment period followed by 12 weeks observation period

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Gassmueller, MD

Organizational Affiliation

bioskin Institute for Dermatological Research and Development GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

bioskin Institute for Dermatological Research and Development GmbH

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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