Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Study Overview
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Brief Summary
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To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

Detailed Description
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Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis. Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.

Official Title
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Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Conditions
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Subcutaneous Fat

Intervention / Treatment
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* Procedure: Noninvasive Radiofrequency TruSculpt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically appreciable localized excess of subcutaneous fat on the submental area no history of systemic underlying disease Exclusion Criteria: any infectious or inflammatory skin diseases keloids psychiatric patients systemic underlying disease who had taken aesthetic procedure on the face, before 6-month more than 5% weight change were dropped out.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Noninvasive Radiofrequency | Procedure: Noninvasive Radiofrequency TruSculpt<br>* Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.<br>* Other names: TruSculpt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in thickness of the submental fat at 6 months | thickness of the submental fat measured by ultrasound | 6 months | 
| Change from Baseline in submental circumference at 6 months | thickness of the submental fat measured by a tape measure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| participants' assessment for improvement at 6 months | assessment for improvement by participants | 6 months | 
| participants' assessment for satisfaction at 6 months | assessment for satisfaction by participants | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency, submental fat, fat reduction, body contouring