What side effects are associated with this type of intervention?

Common treatments for axillary hyperhidrosis include topical antiperspirants, botulinum toxin injections, microwave thermolysis, and radiofrequency microneedling. Specifically, for treatments similar to the InMode radio frequency Pro System with Morpheus8 Applicator, which uses fractional radiofrequency energy, side effects may include temporary redness, swelling, and discomfort at the treatment site. In some cases, patients may experience minor burns or changes in skin pigmentation. These side effects are generally mild and resolve on their own.

What prior FDA approvals exist?

The FDA has approved several treatments for axillary hyperhidrosis, including topical antiperspirants, botulinum toxin injections (such as Botox), and microwave thermolysis (such as the miraDry system). These treatments aim to reduce sweat gland activity through various mechanisms. The InMode radio frequency Pro System with Morpheus8 Applicator, which uses fractional radio frequency energy, is similar to these approved treatments in that it targets sweat glands to reduce excessive sweating. However, specific FDA approval details for this exact system were not provided.

What other types of research exist?

Promising alternatives to the InMode radio frequency Pro System with Morpheus8 Applicator for treating axillary hyperhidrosis include: 1) Modulated electro-hyperthermia (mEHT), which uses capacitive radiofrequency to induce tumor damage and could potentially be adapted for hyperhidrosis treatment. 2) Interstitial microwave hyperthermia applicators, which have been shown to effectively treat deep-seated tumors and may be applicable for sweat gland ablation. 3) Contact Flexible Microstrip Applicators (CFMA) for superficial hyperthermia, which offer precise energy deposition and could be used for targeted sweat gland treatment.

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Radio Frequency

Morpheus8 Radio Frequency Treatment for Axillary Hyperhidrosis

N/A

Recruiting

Led By David E Kent, MD

Research Sponsored by InMode MD Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Must not have

Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.

Female subjects of childbearing potential not willing to use an acceptable form of contraception for the duration of the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin reactions such as redness or swelling at the treatment site, pain during application, possible scarring due to heat exposure from the device, and temporary changes in skin sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I rate my excessive sweating as noticeably bad or intolerable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not willing to use birth control during the study.

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My immune system is weak due to a condition like AIDS or medication.

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I am not pregnant or nursing.

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I do not have severe heart, epilepsy, high blood pressure, or liver/kidney diseases.

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I do not have uncontrolled diabetes, thyroid issues, or abnormal hormone levels.

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I have a history of skin issues like keloids or very dry skin.

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I have not used oral anticholinergic or cholinomimetic medications in the last 4 weeks and do not plan to use them during the study.

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I have had or currently have nerve issues in the limb being treated.

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I have not taken Accutane in the last 6 months.

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I have swollen lymph nodes under my arm.

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I have excessive sweating caused by medication, infection, cancer, or hormonal issues.

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I have or had cancer, including skin cancer or atypical moles.

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I have had surgery or botox injections for excessive sweating in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2

Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.

Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active groupActive Control1 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 groupPlacebo Group1 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).

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Axillary Hyperhidrosis work by targeting the sweat glands to reduce excessive sweating. Fractional Radio Frequency (RF) energy, such as that used in the InMode radio frequency Pro System with Morpheus8 Applicator, delivers RF energy through needle electrodes to heat and disrupt sweat glands, thereby reducing their activity. Botulinum toxin injections block the release of acetylcholine, a neurotransmitter that stimulates sweat production, leading to temporary reduction in sweating. Systemic anticholinergic agents, like glycopyrrolate and oxybutynin, inhibit the action of acetylcholine throughout the body, reducing overall sweat production. These treatments are crucial for patients as they provide effective options to manage excessive sweating, improving quality of life and reducing the social and psychological impact of hyperhidrosis.

Dermatologic facial applications of Morpheus8 fractional radiofrequency microneedling.A Prospective Study of Axillary Hair Reduction in Patients Treated With Microwave Technology.