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Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency
Sponsor: InMode MD Ltd.
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
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-03-09
Completion Date
2026-04
Last Updated
2024-01-12
Healthy Volunteers
Yes
Conditions
Interventions
Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.
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
Locations (4)
Skinfluence
New York, New York, United States
Southeastern Dermatology
Knoxville, Tennessee, United States
Dallas Plastic Surgery Institute
Dallas, Texas, United States
RAMBAM Medical Center
Haifa, Israel