Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Subcutaneous Fat Clinical Trial

— UNIRFFC  

Official title:

Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512822
• Other study ID #: KBC13251D
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: July 30, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Subcutaneous Fat

Intervention

Procedure:
• Noninvasive Radiofrequency TruSculpt
Heating subcutaneous fat up to 45? continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital	Cutera Inc.

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in thickness of the submental fat at 6 months	thickness of the submental fat measured by ultrasound	6 months
Primary	Change from Baseline in submental circumference at 6 months	thickness of the submental fat measured by a tape measure	6 months
Secondary	participants' assessment for improvement at 6 months	assessment for improvement by participants	6 months
Secondary	participants' assessment for satisfaction at 6 months	assessment for satisfaction by participants	6 months