Treatment of Male Pattern Baldness With Botulinum Toxin | NCT00965640

Studies
Treatment of Male Pattern Baldness With Botulinum Toxin

NCT00965640

Sponsor

The Crown Institute

Status

Completed

Last Update Posted

Aug 25, 2009Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Male Pattern Baldness

Interventions

Botulinum Toxin - A injections

Countries

Canada

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

ID	Type	Description	Link
HPB 081023

Status Module

Record Verification Date

Aug 2009

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

Dec 2002

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

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

Aug 24, 2009

Last Update Posted Date

Aug 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe and effective method for treating this form of hair loss.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin - A injections	Drug

Measure	Description	Time Frame
Hair Growth		1 year

Measure	Description	Time Frame
Hair Loss		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male pattern baldness
Norwood II-VI

Exclusion Criteria:

Treatment with Botulinum toxins or other hair growth interventions with past year

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Freund, MD	Crown Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Crown Institute		Pickering	Ontario	L1V 1B1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21042071	Derived	Freund BJ, Schwartz M. Treatment of male pattern baldness with botulinum toxin: a pilot study. Plast Reconstr Surg. 2010 Nov;126(5):246e-248e. doi: 10.1097/PRS.0b013e3181ef816d. No abstract available.

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