HyperhidrosisNCT05546710
miraDry Post Market Tumescent Anesthesia Study
A study testing miraDry treatment in people with Hyperhidrosis and Axillary Hyperhidrosis, run by miraDry, Inc..
Trial summary
This clinical trial will collect data on the safety and efficacy of the miraDry treatment when High Volume Anesthesia (Tumescent Anesthesia) is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis, Axillary Hyperhidrosis
- What is being tested?
- miraDry treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (aged ≥18 years) at time of consent.
- A HDSS score of 3 or 4.
- Excess sweating evidenced by at least two of the following:
- Impairs daily activities b. Frequency of at least one episode per week c. Age of onset less than 25 years old d. Positive family history e. Cessation of focal sweating during sleep d) In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
- Willing and able to comply with protocol requirements and all study visits. f) Female patients 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
- A cardiac pacemaker or cardiac defibrillator or other electronic implant.
- Requires supplemental oxygen.
- Known resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine.
- Secondary excess sweating due to medications, infections, malignancy.
- Evidence of active infection or prone to infection.
- Prior liposuction or other dissection surgery for axillary excess sweating.
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- Oral anticholinergic medication use (e.g., Glycopyrrolate) or cholinomimetic medication use within the last 4 weeks or planned use during the study's follow-up phase.
- Taking any other medication that may hinder post-procedure recovery and/or healing.
- Botulinum treatment of the axilla within the last 12 months.
- Currently participating in or recently participated in another clinical trial (within the last 30 days).
- History of or current neurologic deficit in the treatment area and/or limb.
- History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) a history of successfully treated cancer that have been disease-free for five years.
- Any history of cysts, hidradenitis suppurativa, etc.
- Pre-existing conditions at the time of enrollment that overlap with the list of anticipated AEs (Section 6.1).
- Prior treatment in axillary area with miraDry.
About this study
Official title: Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) Used With the miraDry Treatment for Axillary Hyperhidrosis
This clinical trial will collect data on the safety and efficacy of the miraDry treatment when High Volume Anesthesia (Tumescent Anesthesia) is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. MiraDry system was FDA cleared in 2011 for the treatment of primary axillary hyperhidrosis. The miraDry system is also CE-marked.
Read the detailed description
Hyperhidrosis is a condition defined as sweating beyond what is physiologically required by the body (excessive sweating). Hyperhidrosis sufferers have been shown to suffer from anxiety, social and occupational impairment and limitation of exercise, recreation, and leisure. In addition to psychological and social issues, hyperhidrosis sufferers see significant financial burden from their condition. The costs of treatments which need to be repeated chronically and replacing clothing which is permanently stained and unwearable can amount to significant expenditures over time.
Many physicians using the miraDry System are using alternative methods for anesthetizing the axilla; the most common is infiltrative local tumescent anesthesia (LTA) at a high volume. miraDry often calls this method as High Volume Anesthesia (HVA) and the two terms are used interchangably. Tumescent anesthesia is commonly used for various dermatologic surgery procedures. This method involves using a larger volume of fluid with a lower concentration of lidocaine; the fluid is introduced under the skin through a few small injection sites and infiltrated into the desired region. For this application using the tumescent technique, between 100 and 300 cc's of fluid per axilla would be introduced subcutaneously, depending on the size of the axilla.
This clinical trial will collect data on the safety and efficacy when High Volume Anesthesia is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. The investigators participating in this study are experts in the administration of tumescent anesthesia for dermatologic applications.
- Conditions
- Hyperhidrosis, Axillary Hyperhidrosis
- Being tested
- miraDry treatment
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miraDry treatmentDevice
Also called Tumescent Anesthesia (high-volume anesthesia)
The miraDry device is non-invasive and uses microwave energy, focused at the dermal/hypodermal interface, to thermally impact the sweat glands. The treatment area is identified (hair bearing area of the axilla) and high-volume anesthesia is delivered. The miraDry template is selected based upon the size of the treatment area and temporarily applied to the patient's skin. A new miraDry bioTip is attached to the miraDry Handpiece for each treatment session. The Handpiece is then placed on the surface of the skin in the area to be treated. The treatment cycle is activated by a button on the Handpiece. Multiple placements of the Handpiece are required to treat a full axilla in one treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | miraDry treatment Receives: Device: miraDry treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device and/or treatment related serious adverse events (SAEs)
Incidence of device and/or treatment related serious adverse events (SAEs)
Measured: 30 days
Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2
Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2
Measured: 30 days
Secondary outcomes (4)
Incidence of device and/or treatment related SAEs and AEs
Incidence of device and/or treatment related SAEs and AEs
Measured: 6 months
Responder rate: HDSS score of 1 or 2
Responder rate: HDSS score of 1 or 2
Measured: 3 and 6 months
Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)
Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)
Measured: 30 days, 3 months, and 6 months
Change in odor assessment score from baseline
Change in odor assessment score from baseline
Measured: 30 days, 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 posted21 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Business decision to pivot priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Prospective, single-arm, open-label, multicenter study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- miraDry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546710
- Sponsor's protocol ID
- CP-0024
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) Used With the miraDry Treatment for Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT05546710
- Acronym / sponsor ID
- CP-0024
- Conditions
- Hyperhidrosis, Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to pivot priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- miraDry, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Sep 2022 (actual)
- 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 clinical trial will collect data on the safety and efficacy of the miraDry treatment when High Volume Anesthesia (Tumescent Anesthesia) is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. MiraDry system was FDA cleared in 2011 for the treatment of primary axillary hyperhidrosis. The miraDry system is also CE-marked.
Detailed description
Hyperhidrosis is a condition defined as sweating beyond what is physiologically required by the body (excessive sweating). Hyperhidrosis sufferers have been shown to suffer from anxiety, social and occupational impairment and limitation of exercise, recreation, and leisure. In addition to psychological and social issues, hyperhidrosis sufferers see significant financial burden from their condition. The costs of treatments which need to be repeated chronically and replacing clothing which is permanently stained and unwearable can amount to significant expenditures over time.
Many physicians using the miraDry System are using alternative methods for anesthetizing the axilla; the most common is infiltrative local tumescent anesthesia (LTA) at a high volume. miraDry often calls this method as High Volume Anesthesia (HVA) and the two terms are used interchangably. Tumescent anesthesia is commonly used for various dermatologic surgery procedures. This method involves using a larger volume of fluid with a lower concentration of lidocaine; the fluid is introduced under the skin through a few small injection sites and infiltrated into the desired region. For this application using the tumescent technique, between 100 and 300 cc's of fluid per axilla would be introduced subcutaneously, depending on the size of the axilla.
This clinical trial will collect data on the safety and efficacy when High Volume Anesthesia is used as an alternate method of anesthetizing the axilla prior to the miraDry System being used. The investigators participating in this study are experts in the administration of tumescent anesthesia for dermatologic applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, open-label, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: miraDry treatmentmiraDry treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (aged ≥18 years) at time of consent.
- A HDSS score of 3 or 4.
- Excess sweating evidenced by at least two of the following:
- Impairs daily activities b. Frequency of at least one episode per week c. Age of onset less than 25 years old d. Positive family history e. Cessation of focal sweating during sleep d) In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
- Willing and able to comply with protocol requirements and all study visits. f) Female patients of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study.
Key exclusion criteria (15 listed)
- A cardiac pacemaker or cardiac defibrillator or other electronic implant.
- Requires supplemental oxygen.
- Known resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine.
- Secondary excess sweating due to medications, infections, malignancy.
- Evidence of active infection or prone to infection.
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 treatmentAlso: Tumescent Anesthesia (high-volume anesthesia)The miraDry device is non-invasive and uses microwave energy, focused at the dermal/hypodermal interface, to thermally impact the sweat glands. The treatment area is identified (hair bearing area of the axilla) and high-volume anesthesia is delivered. The miraDry template is selected based upon the size of the treatment area and temporarily applied to the patient's skin. A new miraDry bioTip is attached to the miraDry Handpiece for each treatment session. The Handpiece is then placed on the surface of the skin in the area to be treated. The treatment cycle is activated by a button on the Handpiece. Multiple placements of the Handpiece are required to treat a full axilla in one treatment session. | Device | Treatment Arm |
Primary outcome
Incidence of device and/or treatment related serious adverse events (SAEs)
Time frame: 30 days
Incidence of device and/or treatment related serious adverse events (SAEs)
Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2
Time frame: 30 days
Responder rate: defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2
4 secondary outcomes
Incidence of device and/or treatment related SAEs and AEs
Time frame: 6 months
Responder rate: HDSS score of 1 or 2
Time frame: 3 and 6 months
Change in Quality of Life from baseline as measured by the Dermatology Life Quality Index (DLQI)
Time frame: 30 days, 3 months, and 6 months
Change in odor assessment score from baseline
Time frame: 30 days, 3 months, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing miraDry treatment in people with Hyperhidrosis and Axillary Hyperhidrosis, run by miraDry, Inc..
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of device and/or treatment related serious adverse events (SAEs) (time frame: 30 days). 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 23 Oct 2023.