Morpheus8 Radio Frequency Treatment for Axillary Hyperhidrosis

Recruiting at 4 trial locations

Overseen By Rod Rohrich, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with primary axillary hyperhidrosis, a condition causing excessive underarm sweating. The Morpheus8 Applicator, a device that delivers radio frequency energy to the skin, is used in this study. Participants will receive either the actual treatment or a sham (fake) treatment to compare results. Individuals with noticeable underarm sweating that impacts daily life and began before age 25 may be suitable candidates. As an unphased trial, this study provides an opportunity to explore a novel treatment option for managing excessive underarm sweating.

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.

What prior data suggests that the Morpheus8 Applicator is safe for treating axillary hyperhidrosis?

Research shows that the Morpheus8 Applicator, used to treat excessive underarm sweating, has some safety information available. Studies have also examined its use for other conditions. Generally, people tolerate it well, though some side effects have been reported.

In one study, patients saw improvements in their condition. However, reports of negative effects exist. For instance, one person experienced facial damage after using the device, but this occurred in a different treatment area and situation.

Safety checks continue, and researchers closely monitor the device for any side effects. It's important to know that while risks exist, many people have used the Morpheus8 Applicator without serious problems. Always consider consulting a healthcare provider to decide if joining a trial is right. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for axillary hyperhidrosis, like antiperspirants, oral medications, or Botox injections, focus on reducing sweat production by blocking sweat glands or affecting nervous system signals. But the Morpheus8 Radio Frequency treatment stands out because it uses radiofrequency energy delivered through a specialized applicator to precisely target and disrupt the sweat glands. This approach might offer longer-lasting relief with fewer side effects. Researchers are excited because this method could be a game-changer, providing a non-invasive and potentially more effective solution for those struggling with excessive underarm sweating.

What evidence suggests that the Morpheus8 Applicator is effective for treating axillary hyperhidrosis?

Research shows that the Morpheus8 Applicator might help treat excessive underarm sweating, also known as axillary hyperhidrosis. This trial will compare two groups: an active group receiving the Morpheus8 treatment and a sham group receiving a placebo treatment. The Morpheus8 treatment uses a combination of radiofrequency energy and tiny needles to target and reduce sweat gland activity. Studies have found that this method can safely and effectively decrease sweating, leading to long-lasting results and improved quality of life. Participants report feeling drier and more comfortable in daily activities. This suggests that Morpheus8 could be a promising option for managing excessive underarm sweating. ^{1 6 7 8 9}

Who Is on the Research Team?

Rodney J Rohrich, MD

Principal Investigator

Are You a Good Fit for This Trial?

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 willing and able to follow the study's requirements.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05860972/evaluation-of-safety-and-efficacy-of-morpheus8-applicator-for-the-treatment-of-focal-hyperhidrosis-of-the-axillae-using-radio-frequency

Evaluation of Safety and Efficacy of Morpheus8 Applicator ... Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis DiseaseSeverity Scale (HDSS). Subject has primary focal axillary ...

2. goodvibemedical.com goodvibemedical.com/morpheus8-for-hyperhidrosis/

Morpheus8 for Hyperhidrosis As a minimally-invasive procedure combining microneedling and radiofrequency energy, Morpheus8 aims to safely and effectively reduce excessive underarm sweating ...

3. withpower.com withpower.com/trial/phase-hyperhidrosis-2-2023-7a065

Morpheus8 Radio Frequency Treatment for Axillary ... 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 ...

4. thefergusonclinic.com thefergusonclinic.com/product/morpheus8-hyperhidrosis/

No Sweat: Morpheus8 for Hyperhidrosis (3tx) With minimal downtime and long-lasting results, this treatment provides a promising solution for those seeking relief from excessive underarm sweating. Feel dry ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05830968

Safety and Efficacy of Radio Frequency for the Treatment ... Clinical Evaluation of Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator for the Treatment of Mild to Severe Inflammatory Acne ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20202341&pc=PBX

MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8 (b)(6) was the provider that done this procedure and literally melted my face causing severe facial damage especially to my right eye, she used the needle depth ...

7. inmodemd.com inmodemd.com/wp-content/uploads/2023/01/PeerRev_JOCD_M8Cellulite_NURWAC.pdf

A clinical study to evaluate the safety and efficacy ... Hence, our objective was to evaluate the safety and efficacy of the Morpheus8 Body 40- pin tip at a depth of up to 6 mm for treat- ment of the thighs to improve ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT03769649/Prot_SAP_000.pdf

Clinical Evaluation of Safety and Efficacy of The CelluTite ... Safety Endpoint. Observation, assessment and recording of adverse events. Evaluations will be done immediately after treatments and at all follow-up visit.

9. app.trialscreen.org app.trialscreen.org/trials/hyperhidrosis-primary-focal-axilla-evaluation-safety-efficacy-morpheus8-trial-nct05860972

Evaluation of Safety and Efficacy of Morpheus8 Applicator ... This study aims to evaluate the safety and efficacy of the Morpheus8 Applicator, which uses radio frequency energy, in treating excessive underarm sweating.