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RECRUITING
NCT05860972
NA

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

Sponsor: InMode MD Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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