Alopecia AreataNCT00408798
Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
A study testing Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units in people with Alopecia Areata, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to examine prospectively the safety and efficacy of Botulinum Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to 30 Oct 2009
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with long standing alopecia areata, patches must be at least 4 cm in diameter
Who cannot join
- Intake of drugs that interfere with Botulinum toxin A such as gentamicin, tobramycin, clindamycin and lincomycin; medications used to treat heart rhythm problems, such as quinidine; and medications used to treat other conditions, such as myasthenia gravis, ALS or Alzheimer's disease.
- Neuromuscular disorders such as Myasthenia gravis and Lambert-Eaton-Syndrome.
- Treatment with another investigational drug within 4 weeks prior to anticipated first treatment.
- Females who are pregnant, planning to become pregnant during the study period, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Dermatology, The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
About this study
The purpose of this study is to examine prospectively the safety and efficacy of Botulinum Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.
Read the detailed description
Hypothesis Intralesional injections of Botulinum Toxin A can be used as a treatment for AA. Potential points of action of this treatment include changes in neurotransmitters, which either directly or via neuroimmunologic mechanisms influence cytocines that are responsible for the hair growth arrest in alopecia areata.
Justification Botulinum Toxin A is an antagonist of Acetylcholine esterase and is used to treat facial wrinkles and hyperhidrosis. One ampoule contains Clostridium Botulinum Toxin Typ A (900kD) 100 E, other components are human albumin and sodium choride. The investigator has learnt about the potential effect of this treatment in AA from personal communication.
Objectives Over a period of 6 month, to assess the therapeutic efficacy and safety of a regimen of two interlesional injections of Botulinum Toxin A at 0 and 3 months, in patients with alopecia areata of the scalp, compared to placebo.
Research Method A total of 20 eligible patients will be enrolled in the study. All patients will receive treatment into one half of their target area and placebo treatment into the other half of their target area.
Measurement of the severity of scalp alopecia areata will be based on the extent terminal scalp hair loss. The Severity of Alopecia Tool (SALT) will be used, which determines the percent of scalp involvement with disease as calculated according to specifications detailed in the Alopecia Areata Investigational Guidelines by Olsen et al..
A circular target area of at least 4 cm diameter will be chosen on the scalp.
At visit 0 and after 3 months at visit 1, the two right quandrants of the target area will each be injected with either Botulinum Toxin A (Botox) at a dose of 10 Units (0.1 cc) or saline 0.9% with a total of 0.1 cc.
The left two quadrants will be injected with the other medication. The patient will not know which half of the target area is injected with the drug or placebo.
The chosen side will be noted in the patient documentation by one investigator. The second investigator who does the efficacy assessment with the qualitative scale will not know which side is treated with Botulinum Toxin A or placebo.
At every visit, extent of the hair loss in the test area will be examined, based on a semi quantitative assessment scale ranging from 0 to 100. The investigator does not know which side had been treated.
There had been unpublished anecdotal reports of the use and the efficacy of Botulinumtoxin A in patients with alopecia areata. No further evidence is available so fare.
- Conditions
- Alopecia Areata
- Being tested
- Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
- Keywords
- Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 unitsDrug
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
Secondary outcomes (1)
Hair regrowth will be assessed after 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startOct 2007
- Primary completion30 Oct 2009
- Study completion30 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Shapiro, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408798
- Sponsor's protocol ID
- H06-00278
- Other IDs
- Health Canada: Control #108512
- Status last verified
- Mar 2017
- First submitted
- 5 Dec 2006
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
- ClinicalTrials.gov ID
- NCT00408798
- Acronym / sponsor ID
- H06-00278
- Conditions
- Alopecia Areata
- Keywords
- Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- 30 Oct 2009 (actual)
- Study completion
- 30 Oct 2009 (actual)
- First posted
- 7 Dec 2006 (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.
The purpose of this study is to examine prospectively the safety and efficacy of Botulinum Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.
Detailed description
Hypothesis Intralesional injections of Botulinum Toxin A can be used as a treatment for AA. Potential points of action of this treatment include changes in neurotransmitters, which either directly or via neuroimmunologic mechanisms influence cytocines that are responsible for the hair growth arrest in alopecia areata.
Justification Botulinum Toxin A is an antagonist of Acetylcholine esterase and is used to treat facial wrinkles and hyperhidrosis. One ampoule contains Clostridium Botulinum Toxin Typ A (900kD) 100 E, other components are human albumin and sodium choride. The investigator has learnt about the potential effect of this treatment in AA from personal communication.
Objectives Over a period of 6 month, to assess the therapeutic efficacy and safety of a regimen of two interlesional injections of Botulinum Toxin A at 0 and 3 months, in patients with alopecia areata of the scalp, compared to placebo.
Research Method A total of 20 eligible patients will be enrolled in the study. All patients will receive treatment into one half of their target area and placebo treatment into the other half of their target area.
Measurement of the severity of scalp alopecia areata will be based on the extent terminal scalp hair loss. The Severity of Alopecia Tool (SALT) will be used, which determines the percent of scalp involvement with disease as calculated according to specifications detailed in the Alopecia Areata Investigational Guidelines by Olsen et al..
A circular target area of at least 4 cm diameter will be chosen on the scalp.
At visit 0 and after 3 months at visit 1, the two right quandrants of the target area will each be injected with either Botulinum Toxin A (Botox) at a dose of 10 Units (0.1 cc) or saline 0.9% with a total of 0.1 cc.
The left two quadrants will be injected with the other medication. The patient will not know which half of the target area is injected with the drug or placebo.
The chosen side will be noted in the patient documentation by one investigator. The second investigator who does the efficacy assessment with the qualitative scale will not know which side is treated with Botulinum Toxin A or placebo.
At every visit, extent of the hair loss in the test area will be examined, based on a semi quantitative assessment scale ranging from 0 to 100. The investigator does not know which side had been treated.
There had been unpublished anecdotal reports of the use and the efficacy of Botulinumtoxin A in patients with alopecia areata. No further evidence is available so fare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with long standing alopecia areata, patches must be at least 4 cm in diameter
Key exclusion criteria (4 listed)
- Intake of drugs that interfere with Botulinum toxin A such as gentamicin, tobramycin, clindamycin and lincomycin; medications used to treat heart rhythm problems, such as quinidine; and medications used to treat other conditions, such as myasthenia gravis, ALS or Alzheimer's disease.
- Neuromuscular disorders such as Myasthenia gravis and Lambert-Eaton-Syndrome.
- Treatment with another investigational drug within 4 weeks prior to anticipated first treatment.
- Females who are pregnant, planning to become pregnant during the study period, or breastfeeding.
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 |
|---|---|---|
| Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 unitsSee Detailed Description. | Drug | – |
Primary outcome
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
1 secondary outcome
Hair regrowth will be assessed after 3 months and 6 months
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 3 Mar 2017.
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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.
Jerry Shapiro, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units in people with Alopecia Areata, run by University of British Columbia 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 1 inclusion and 4 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 3 Mar 2017. 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.
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?
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2017.