Male Pattern BaldnessPhase 2NCT00965640
Treatment of Male Pattern Baldness With Botulinum Toxin
A Phase 2 study testing Botulinum Toxin - A injections in people with Male Pattern Baldness, run by The Crown Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Pattern Baldness
- What is being tested?
- Botulinum Toxin - A injections
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Dec 2002to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male pattern baldness
- Norwood II-VI
Who cannot join
- Treatment with Botulinum toxins or other hair growth interventions with past year
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Male Pattern Baldness
- Being tested
- Botulinum Toxin - A injections
- Keywords
- male pattern baldness, androgenetic alopecia, hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin - A injectionsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Growth
Measured: 1 year
Secondary outcomes (1)
Hair Loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startDec 2002
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Pattern BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- The Crown Institute
- Sponsor type
- University, hospital or other
- Investigators
- Brian Freund, MD, Principal investigator, Crown Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965640
- Sponsor's protocol ID
- MPB-2002-01
- Other IDs
- HPB 081023
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21042071
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00965640
- Acronym / sponsor ID
- MPB-2002-01
- Conditions
- Male Pattern Baldness
- Keywords
- male pattern baldness, androgenetic alopecia, hair loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Crown InstituteUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male pattern baldness
- Norwood II-VI
Key exclusion criteria (1 listed)
- Treatment with Botulinum toxins or other hair growth interventions with past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin - A injections | Drug | – |
Primary outcome
Hair Growth
Time frame: 1 year
1 secondary outcome
Hair Loss
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Derived from this study: PubMed 21042071Freund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Freund, MD principal investigator
Crown Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin - A injections in people with Male Pattern Baldness, run by The Crown Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Growth (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.