Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000821796
Ethics application status
Not required
Date submitted
18/04/2013
Date registered
25/07/2013
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Date results information initially provided
14/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum toxin as a hair loss treatment
Scientific title
In male and female pattern hair loss does Botulinum toxin Type A at a 20 unit dose increase hair bulk?
Secondary ID [1] 282363 0
NIL
Universal Trial Number (UTN)
U1111-1142-0932
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic alopecia 288938 0
Condition category
Condition code
Skin 289275 289275 0 0
Dermatological conditions
Metabolic and Endocrine 289436 289436 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Botulinum toxin Type A 20 units by intramuscular injection administered twice three months apart.
Intervention code [1] 286992 0
Treatment: Drugs
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289380 0
Hair bulk as measured with Haircheck device
Timepoint [1] 289380 0
Six months
Secondary outcome [1] 302383 0
None
Timepoint [1] 302383 0
None

Eligibility
Key inclusion criteria
Men and women with androgenetic alopecia who have not changed their hair loss treatment in the preceding three months.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent change (last three months) of hair loss treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients invited to participate via a newsletter delivered to all current patients. Those that meeting the inclusion criteria undergo treatment. There is no control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Dependent t-test of whether any difference is statistically significant. Number of participants determined by funding level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2013
Actual
14/01/2013
Date of last participant enrolment
Anticipated
21/02/2013
Actual
22/02/2013
Date of last data collection
Anticipated
Actual
31/07/2013
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 5024 0
New Zealand
State/province [1] 5024 0
Auckland

Funding & Sponsors
Funding source category [1] 287131 0
Self funded/Unfunded
Name [1] 287131 0
Paul Nola
Ponsonby Cosmetic Medical Clinic
Country [1] 287131 0
New Zealand
Primary sponsor type
Individual
Name
Paul Nola
Address
Medical Director
Ponsonby Cosmetic Medical Clinic
Level One 63 Ponsonby Road
Ponsonby
Auckland 1011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285902 0
None
Name [1] 285902 0
Address [1] 285902 0
Country [1] 285902 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 289136 0
None
Ethics committee address [1] 289136 0
Botulinum toxin treatment of frontalis and occipitalis is a common cosmetic treatment and treatment for headache. The new element in this study is the measurement of hair bulk. After personal discussion with an ethics committee member it was advised that ethics committee approval was not required.
Ethics committee country [1] 289136 0
New Zealand
Date submitted for ethics approval [1] 289136 0
08/05/2013
Approval date [1] 289136 0
Ethics approval number [1] 289136 0

Summary
Brief summary
Current treatments for male and female pattern hair loss are not infrequently inadequately effective or are poorly tolerated. New treatments modalities are eagerly anticipated by both hair loss sufferers and those that care for them.

A case series of 50 patients treated with 150 units of botulinum toxin twice in six months demonstrated a response rate of 75% and an average hair count increase of 18% at 12 months. The financial burden of this dose of toxin limits the number of patients that could benefit from this treatment.

Further study of the anatomy of the scalp generates the hypothesis that 20 units of botulinum toxin may be enough to deliver the same benefits. Toxin will also be administered in a more conventional three monthly dosing schedule.
Trial website
www.hairdoctor.co.nz
Trial related presentations / publications
Public notes
Ethical Committee approval not required. Unable to proceed with posting trial data without inputing a date for Ethics Committee submission.

Contacts
Principal investigator
Name 39422 0
Dr Paul Nola
Address 39422 0
Medical Director
Ponsonby Cosmetic Medical Clinic
Level One 63 Ponsonby Road
Ponsonby
Auckland 1011
New Zealand
Country 39422 0
New Zealand
Phone 39422 0
+6493604078
Fax 39422 0
Email 39422 0
[email protected]
Contact person for public queries
Name 39423 0
Dr Paul Nola
Address 39423 0
Medical Director
Ponsonby Cosmetic Medical Clinic
Level One 63 Ponsonby Road
Ponsonby
Auckland 1011
Country 39423 0
New Zealand
Phone 39423 0
+6493604078
Fax 39423 0
Email 39423 0
[email protected]
Contact person for scientific queries
Name 39424 0
Dr Paul Nola
Address 39424 0
Medical Director
Ponsonby Cosmetic Medical Clinic
Level One 63 Ponsonby Road
Ponsonby
Auckland 1011
Country 39424 0
New Zealand
Phone 39424 0
+6493604078
Fax 39424 0
Email 39424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not given


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo No benefit shown.

Documents added automatically
No additional documents have been identified.