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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial tested a computerized system which uses radio frequency energy to treat sweat gland issues in the armpit area.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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).

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,295 Total Patients Enrolled
David E Kent, MDPrincipal InvestigatorUnafilliated
Rodney J Rohrich, MDPrincipal Investigator

Media Library

Morpheus8 Applicator (Radio Frequency) Clinical Trial Eligibility Overview. Trial Name: NCT05860972 — N/A
Axillary Hyperhidrosis Research Study Groups: Active group, Sham group
Axillary Hyperhidrosis Clinical Trial 2023: Morpheus8 Applicator Highlights & Side Effects. Trial Name: NCT05860972 — N/A
Morpheus8 Applicator (Radio Frequency) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05860972 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers accepted at this point in the clinical trial?

"This investigative research is not currently enrolling participants as per the information provided on clinicaltrials.gov; it was initially published in March of 2023 and last modified in May of that same year. However, 8 other trials are actively seeking patients right now."

Answered by AI

Who else is applying?

What site did they apply to?
Southeastern Dermatology
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried Glycopyrrolate, Oxybutynin, Clonidine, Drysol, and Botox.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency
2023. "Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05860972.
All > Hyperhidrosis
~32 spots leftby Apr 2025
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