Morpheus8 Radio Frequency Treatment for Axillary Hyperhidrosis

Recruiting at 4 trial locations

Overseen By Maria Shusterman, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InMode MD Ltd.

Must not be taking: Anticoagulants, Isotretinoin, Anticholinergics, Cholinomimetics

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a device that uses radio waves to treat people with excessive underarm sweating. The device works by heating and reducing the activity of sweat glands. Participants' progress will be monitored for several months.

Will I have to stop taking my current medications?

The trial requires you to stop using oral anticholinergic medications (like Robinul) and cholinomimetic medications at least 4 weeks before and during the study. If you are taking Isotretinoin (Accutane), you must stop 6 months before the study. Also, you should not have used anticoagulants in the last 10 days.

How does the Morpheus8 treatment for axillary hyperhidrosis differ from other treatments?

The Morpheus8 treatment for axillary hyperhidrosis is unique because it uses radio frequency energy to target and reduce sweat glands, unlike other treatments that may use microwave energy to heat the skin-fat interface. This approach can offer a different mechanism of action compared to existing microwave-based therapies. ^{1 2 3 4 5}

Research Team

Rodney J Rohrich, MD

Principal Investigator

Eligibility Criteria

This trial is for adults over 18 with primary focal axillary hyperhidrosis, which causes excessive underarm sweating impacting daily life. Participants must have had this condition from a young age, experience it regularly, and not sweat while sleeping. They should be able to follow the study plan and agree to use contraception if applicable. People with skin disorders, recent drug treatments that affect sweating, certain medical implants or conditions like uncontrolled hypertension or diabetes can't join.

Inclusion Criteria

Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.

I have had excessive underarm sweating for over 6 months that affects my daily life and started before I was 25.

I am 18 years old or older.

Exclusion Criteria

Injury in the treatment area or any other condition that, in the opinion of the investigator, might make treatment unsafe.

Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).

I have an active skin condition like sores or eczema in the treatment area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator or 2 sham treatments

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 1 month, 3 months, and 6 months

Treatment Details

Interventions

• Morpheus8 Applicator

Trial Overview The Morpheus8 Applicator using radio frequency energy is being tested for treating excessive underarm sweating (axillary hyperhidrosis). This device uses Fractional RF technology aimed at reducing sweat production in the area treated. The study will evaluate how safe and effective this treatment is compared to current methods.

Participant Groups

Group I: Active group Active Control 1 Intervention

Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip)

Group II: Sham group Placebo Group 1 Intervention

Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip).

Morpheus8 Applicator is already approved in United States, European Union for the following indications:

Approved in United States as InMode RF Pro System with Morpheus8 Applicator for:

• Electrocoagulation and hemostasis in dermatological procedures
• Treatment of mild, moderate, and severe facial acne vulgaris

Approved in European Union as InMode RF Pro System with Morpheus8 Applicator for:

• Electrocoagulation and hemostasis in dermatological procedures

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Recruited

1,500+

Findings from Research

The study presents a novel approach combining the starch-iodine technique with tumescent liposuction to effectively treat axillary hyperhidrosis, a condition characterized by excessive sweating in the armpits.

This method is highlighted as both safe and effective, offering a permanent solution compared to traditional treatments that often have significant drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of axillary hyperhidrosis: combination of the starch-iodine test with the tumescent liposuction technique. Swinehart, JM.[2019]

In a study involving 31 adults with primary axillary hyperhidrosis, a microwave-based device effectively reduced sweating, with 90.3% of participants reporting significant improvements in sweat severity and quality of life after 12 months.

While the treatment was generally safe, with transient side effects like swelling and altered sensation, all adverse effects resolved, indicating a favorable safety profile for the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a microwave device for treating axillary hyperhidrosis. Hong, HC., Lupin, M., O'Shaughnessy, KF.[2022]

A systematic review of five clinical trials involving 189 patients found that microwave-based treatment for axillary hyperhidrosis showed long-term efficacy and was associated with mild adverse effects.

Most patients reported satisfaction with the outcomes of the microwave treatment, suggesting it could be a promising alternative for managing excessive sweating in the underarms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of microwave-based therapy for axillary hyperhidrosis. Hsu, TH., Chen, YT., Tu, YK., et al.[2018]

A new microwave procedure for treating axillary hyperhidrosis showed a high responder rate of 89% at 30 days post-treatment, compared to 54% in the sham group, indicating significant efficacy in reducing excessive sweating.

The treatment maintained stable efficacy over 12 months, with 69% of subjects still responding positively, and adverse events were mostly mild and resolved over time, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Glaser, DA., Coleman, WP., Fan, LK., et al.[2022]

In a study of 11 Asian patients treated with a microwave-based device for axillary hyperhidrosis and osmidrosis, 83.3% showed significant improvement in sweating severity after 7 months, indicating strong efficacy.

The treatment was well tolerated, with only one case of temporary altered sensation, suggesting a favorable safety profile for this novel approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a microwave device for treating axillary hyperhidrosis and osmidrosis in Asians: a preliminary study. Lee, SJ., Chang, KY., Suh, DH., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of axillary hyperhidrosis: combination of the starch-iodine test with the tumescent liposuction technique. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a microwave device for treating axillary hyperhidrosis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of microwave-based therapy for axillary hyperhidrosis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The efficacy of a microwave device for treating axillary hyperhidrosis and osmidrosis in Asians: a preliminary study. [2022]