Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
NCT ID: NCT02512822
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2013-11-30
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Participants
Noninvasive Radiofrequency
Noninvasive Radiofrequency TruSculpt
Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Interventions
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Noninvasive Radiofrequency TruSculpt
Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no history of systemic underlying disease
Exclusion Criteria
* 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.
20 Years
75 Years
ALL
Yes
Sponsors
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Cutera Inc.
INDUSTRY
Kangbuk Samsung Hospital
OTHER
Responsible Party
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Won-Serk Kim
Associate professor
Principal Investigators
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Won-Serk Kim, M.D., Ph.D.
Role: STUDY_DIRECTOR
Kangbuk Samsung Hospital
References
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Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925.
Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876.
Other Identifiers
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KBC13251D
Identifier Type: -
Identifier Source: org_study_id