Back to resultsTreatment of Male Pattern Baldness With Botulinum Toxin
Primary Purpose
Male Pattern Baldness
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Botulinum Toxin - A injections
Sponsored by
About this trial
This is an interventional screening trial for Male Pattern Baldness focused on measuring male pattern baldness, androgenetic alopecia, hair loss
Eligibility Criteria
Inclusion Criteria:
- Male pattern baldness
- Norwood II-VI
Exclusion Criteria:
- Treatment with Botulinum toxins or other hair growth interventions with past year
Sites / Locations
- Crown Institute
Outcomes
Primary Outcome Measures
Hair Growth
Secondary Outcome Measures
Hair Loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00965640
Brief Title
Treatment of Male Pattern Baldness With Botulinum Toxin
Official Title
A Prospective, Single Center, Open Label, Proof of Principle Study to Assess the Efficacy and Safety of 150 Units of Botulinum Toxin-A Intra-Muscular Injection in the Prevention of Hair Loss in Men With Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Crown Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Pattern Baldness
Keywords
male pattern baldness, androgenetic alopecia, hair loss
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin - A injections
Primary Outcome Measure Information:
Title
Hair Growth
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hair Loss
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male pattern baldness
Norwood II-VI
Exclusion Criteria:
Treatment with Botulinum toxins or other hair growth interventions with past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Freund, MD
Organizational Affiliation
Crown Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Crown Institute
City
Pickering
State/Province
Ontario
ZIP/Postal Code
L1V 1B1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21042071
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Male Pattern Baldness With Botulinum Toxin
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