Efficacy Study of Topical NEOSH101 to Treat Male Pattern... | NCT00418730

Studies
Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

NCT00418730

Sponsor

Neosil, Inc.

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

180Actual

Phase

Phase 2

Conditions

Androgenetic Alopecia

Interventions

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 3, 2007

First Submission Date that Met QC Criteria

Jan 4, 2007

First Posted Date

Jan 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2008

Last Update Posted Date

May 20, 2008Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
2	Active Comparator	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
3	Placebo Comparator	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	Drug	Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johannes Gassmueller, MD	Bioskin GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
bioskin Institute for Dermatological Research and Development GmbH		Hamburg		20095	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided