search
Back to results

Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency

Primary Purpose

Hyperhidrosis Primary Focal Axilla

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.
Sponsored by
InMode MD Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis Primary Focal Axilla focused on measuring hyperhidrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • Skin Care Physicians of Georgia
  • Dallas Plastic Surgery InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active group

Sham group

Arm Description

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

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

Outcomes

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
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

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
May 5, 2023
Last Updated
June 21, 2023
Sponsor
InMode MD Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05860972
Brief Title
Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InMode MD Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis Primary Focal Axilla
Keywords
hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
The treatments will be performed by an operator/technician who will not be blinded to the type of treatment that the subject is receiving. Objective assessment of clinical improvements such as starch-iodine tests will administered by blinded study personnel. The blinded evaluators will review photographs of the treatment areas that underwent the starch-iodine test and will be blinded as to which photos were taken at the baseline, 4-week follow-up, 12-week follow-up and 24-week follow-up visits. The HDSS, which is an objective assessment, will also be evaluated by a blinded study personnel. All subjects and study staff will be unblinded at the end of the study.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Active Comparator
Arm Description
Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip)
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip).
Intervention Type
Device
Intervention Name(s)
Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity
Description
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
Time Frame
4 weeks
Title
Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2
Description
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.
Time Frame
12 weeks
Title
Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meital Matalon, MS
Phone
949 258-8870
Email
meital.matalon@inmodemd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Shusterman, RN
Phone
9492396522
Email
maria.shusterman@inmodemd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney J Rohrich, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Kent, MD
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Care Physicians of Georgia
City
Warner Robins
State/Province
Georgia
ZIP/Postal Code
31088
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Robertson
Phone
478-742-2180
Email
jrobertson@scpog.com
Facility Name
Dallas Plastic Surgery Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
:Rachelle Winkle, RN
Phone
214-821-9114
Email
rachelle.winkle@dpsi.org
First Name & Middle Initial & Last Name & Degree
Rod Rohrich, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency

We'll reach out to this number within 24 hrs