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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Active Comparator | Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip) |
|
| Sham group | Sham Comparator | Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis. | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 |
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Inclusion Criteria:
Subject is 18 years of age or older at the time of consent.
Exclusion Criteria:
Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meital Matalon, MS | Contact | 949 258-8870 | meital.matalon@inmodemd.com | |
| Maria Shusterman, RN | Contact | 9492396522 | maria.shusterman@inmodemd.com |
| Name | Affiliation | Role |
|---|---|---|
| Rodney J Rohrich, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skinfluence | Active, not recruiting | New York | New York | 11746 | United States | |
| Southeastern Dermatology |
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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.
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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.
|
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. |
| 12 weeks |
| 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 | 4 weeks |
| Recruiting |
| Knoxville |
| Tennessee |
| 37922 |
| United States |
|
| Dallas Plastic Surgery Institute | Recruiting | Dallas | Texas | 75231 | United States |
|
| RAMBAM Medical Center | Not yet recruiting | Haifa | Israel |
|
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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