Hyperhidrosis Primary Focal AxillaNCT05860972
Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency
A study testing Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis. in people with Hyperhidrosis Primary Focal Axilla, run by InMode MD Ltd. at 4 sites in 2 countries.
Trial summary
The InMode radio frequency Pro System with the Morpheus8 Applicator is a computerized system generating radio frequency energy, based on the underlying technology of Fractional RF. The Morpheus8 Applicator and 24 pin tip is used for the treatment of primary hyperhidrosis of the axillae Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis Primary Focal Axilla
- What is being tested?
- Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Mar 2023to Apr 2026
- 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
- 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 (HDSS).
- Subject has primary focal axillary hyperhidrosis evidenced by at least 6 months of visible, detectable, focal, exaggerated sweating without any apparent explanation and at least two of the following:
- Bilateral and relatively symmetric
- Impairs daily activities
- Frequency of at least one episode per week
Show all 12Show fewer
- Age of onset less than 25 years old
- Positive family history
- Cessation of focal sweating during sleep
- Subject is willing and able to comply with protocol requirements and all study visits
- Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
- Subject understands the study and has provided written informed consent
Who cannot join
- Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.
- Swollen axillary lymph nodes.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
Show all 20Show fewer
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
- Prior endoscopic thoracic sympathectomy, liposuction or other surgery for hyperhidrosis in the treated area. Injection of botulinum toxin in the treated area within one year
- Use of Isotretinoin (Accutane®) within 6 months prior to study
- Oral anticholinergic medication use (e.g., Robinul) or cholinomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
- 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).
- Current or history of cancer, including skin cancer, or premalignant moles.
- Injury in the treatment area or any other condition that, in the opinion of the investigator, might make treatment unsafe.
- Subject has a pacemaker, defibrillator or other electronic implant anywhere in the body.
- Permanent implant in the treated area such as metal plates, screws and metal piercing or silicon.
- Females who are pregnant or nursing
- Female subjects of childbearing potential not willing to use an acceptable form of contraception for the duration of the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 2 recruiting
- Recruiting
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
:Rachelle Winkle, RN, 214-821-9114, rachelle.winkle@dpsi.org
Rod Rohrich, MD
- Recruiting
Southeastern Dermatology
Knoxville, Tennessee, 37922
Prianca Patel, 865-474-8800, ppatel@drdoppelt.com
- Active, not recruiting
Skinfluence
New York, New York, 11746
Israel1 site, 1 recruiting
- Not yet recruiting
RAMBAM Medical Center
Haifa
Rinat Lasker, +972 4 777 1738, r_lasker@rambam.health.gov.il
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator (With the 24 Pin Tip) for the Treatment of Primary Focal Hyperhidrosis of the Axillae Using Fractional RF Technology
The InMode radio frequency Pro System with the Morpheus8 Applicator is a computerized system generating radio frequency energy, based on the underlying technology of Fractional RF. The Morpheus8 Applicator and 24 pin tip is used for the treatment of primary hyperhidrosis of the axillae
Read the detailed description
Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode radio frequency Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode radio frequency Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post treatment
- Conditions
- Hyperhidrosis Primary Focal Axilla
- Being tested
- Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.
- 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.
Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.Device
After subjects meet the eligibility criteria, they will be randomized with a 1:1 ratio to one of two treatment groups: Active or Sham. Subjects will receive two active or sham treatments, one month apart, with the InMode RF Pro System with the Morpheus8 Applicator and 24 pins tip and will return for three follow up visits: 4 weeks 12 weeks and 24 weeks post the second treatment
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip) Receives: Device: Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis. |
| Sham group | Sham comparator | Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Receives: Device: Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week
A statistically significant difference in the percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week follow-up visit, in the treatment group compared to the sham group
Measured: 4 weeks
Secondary outcomes (3)
Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity
Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity Visual Scale at the 4-week follow-up visit in the treatment group compared to the sham group
Measured: 4 weeks
Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2
Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 12-week follow-up visit in the treatment group compared to the sham group.
Measured: 12 weeks
Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.
Percent of subjects who achieved a 2-point or greater decline in Hyperhidrosis Disease Severity Scale. from baseline at 4 weeks follow-up in the treatment group compared to the sham group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start9 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperhidrosis Primary Focal AxillaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney J Rohrich, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860972
- Sponsor's protocol ID
- DO611232A
- Status last verified
- Jun 2023
- First submitted
- 5 May 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator (With the 24 Pin Tip) for the Treatment of Primary Focal Hyperhidrosis of the Axillae Using Fractional RF Technology
- ClinicalTrials.gov ID
- NCT05860972
- Acronym / sponsor ID
- DO611232A
- Conditions
- Hyperhidrosis Primary Focal Axilla
- Keywords
- hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 May 2023 (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.
The InMode radio frequency Pro System with the Morpheus8 Applicator is a computerized system generating radio frequency energy, based on the underlying technology of Fractional RF. The Morpheus8 Applicator and 24 pin tip is used for the treatment of primary hyperhidrosis of the axillae
Detailed description
Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode radio frequency Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode radio frequency Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post treatment.
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip) |
| Sham group | Sham comparator | Device: Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (HDSS).
- Subject has primary focal axillary hyperhidrosis evidenced by at least 6 months of visible, detectable, focal, exaggerated sweating without any apparent explanation and at least two of the following:
- Bilateral and relatively symmetric
- Impairs daily activities
Key exclusion criteria (20 listed)
- Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.
- Swollen axillary lymph nodes.
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 |
|---|---|---|
| Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.After subjects meet the eligibility criteria, they will be randomized with a 1:1 ratio to one of two treatment groups: Active or Sham. Subjects will receive two active or sham treatments, one month apart, with the InMode RF Pro System with the Morpheus8 Applicator and 24 pins tip and will return for three follow up visits: 4 weeks 12 weeks and 24 weeks post the second treatment | Device | Active group, Sham group |
Primary outcome
A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week
Time frame: 4 weeks
A statistically significant difference in the percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week follow-up visit, in the treatment group compared to the sham group
3 secondary outcomes
Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity
Time frame: 4 weeks
Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2
Time frame: 12 weeks
Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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.
Rodney J Rohrich, MD principal investigator
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis. in people with Hyperhidrosis Primary Focal Axilla, run by InMode MD Ltd. at 4 sites in 2 countries.
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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meital Matalon, MS (949 258-8870, meital.matalon@inmodemd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week (time frame: 4 weeks). 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 12 Jan 2024.