Axillary HyperhidrosisNCT01091129
Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis
A study testing miraDry System (treatment with energy) in people with Axillary Hyperhidrosis, run by Miramar Labs at 2 sites in Canada.
Trial summary
The purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- miraDry System (treatment with energy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2010to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older at the time of consent.
- Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale.
- Subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla.
- Subject has primary focal axillary hyperhidrosis evidenced by at least two of the following:
- Bilateral and relatively symmetric
- Impairs daily activities
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- Frequency of at least one episode per week
- Age of onset less than 25 years old
- Positive family history
- Cessation of focal sweating during sleep.
- In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
- Subject has provided written informed consent using a form that has been approved by the reviewing IRB/ethics committee.
- Subject is willing and able to comply with protocol requirements and all study visits.
- Female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study.
Who cannot join
- Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
- Subject has hyperhidrosis on the trunk or chest.
- Subject has evidence of active infection.
- Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis.
- Axillary injection of botulinum toxin within one year preceding the miraDry treatment.
- Oral anticholinergic medication use (e.g., Robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
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- Subject is a prisoner or under incarceration.
- Currently participating in or recently participated in another clinical trial (within the last 30 days).
- History of or current neurologic deficit in the treatment limb.
- Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
- History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years.
- Injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for DTS treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy).
- Subject has a pacemaker, defibrillator or other electronic implant
- Subject requires supplemental oxygen.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
Cosmedica
Victoria, British Columbia, V8R 6V4
About this study
The purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).
- Conditions
- Axillary Hyperhidrosis
- Being tested
- miraDry System (treatment with energy)
- Keywords
- hyperhidrosis
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miraDry System (treatment with energy)Device
Also called miraDry System
Treatment with microwave energy delivery device as specified by manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the miraDry System in both axilla Receives: Device: miraDry System (treatment with energy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects that rate themselves as HDSS of 1 or 2 at the 30 day follow-up visit will be greater than 50% with a 95% confidence.
Measured: 30 days after final treatment session
Rate of serious adverse events
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary HyperhidrosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miramar Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chih-ho Hong, MD, Principal investigator, Guildford Dermatology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091129
- Sponsor's protocol ID
- CP-0004
- Status last verified
- Dec 2014
- First submitted
- 19 Mar 2010
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01091129
- Acronym / sponsor ID
- CP-0004
- Conditions
- Axillary Hyperhidrosis
- Keywords
- hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Miramar LabsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Mar 2010 (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 determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: miraDry System (treatment with energy)Treatment with the miraDry System in both axilla |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is 18 years of age or older at the time of consent.
- Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale.
- Subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla.
- Subject has primary focal axillary hyperhidrosis evidenced by at least two of the following:
- In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
Key exclusion criteria (14 listed)
- Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
- Subject has hyperhidrosis on the trunk or chest.
- Subject has evidence of active infection.
- Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis.
- Axillary injection of botulinum toxin within one year preceding the miraDry treatment.
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 |
|---|---|---|
| miraDry System (treatment with energy)Also: miraDry SystemTreatment with microwave energy delivery device as specified by manufacturer's instructions | Device | Treatment |
Primary outcome
The proportion of subjects that rate themselves as HDSS of 1 or 2 at the 30 day follow-up visit will be greater than 50% with a 95% confidence.
Time frame: 30 days after final treatment session
Rate of serious adverse events
Time frame: 12 months post treatment
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 9 Dec 2014.
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.
Chih-ho Hong, MD principal investigator
Guildford Dermatology Specialists
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miraDry System (treatment with energy) in people with Axillary Hyperhidrosis, run by Miramar Labs at 2 sites 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 14 inclusion and 14 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The proportion of subjects that rate themselves as HDSS of 1 or 2 at the 30 day follow-up visit will be greater than 50% with a 95% confidence. (time frame: 30 days after final treatment session). The study lists 2 primary outcomes in all. 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 9 Dec 2014.