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OpenTrials
Completed

NCT Number: NCT02512822

Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

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

Completed

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Key information

Conditions

Subcutaneous Fat

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noninvasive Radiofrequency TruSculpt

Procedure

Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.

Other names: TruSculpt

Primary outcomes

  1. Change from Baseline in thickness of the submental fat at 6 months

    Time frame: 6 months

    thickness of the submental fat measured by ultrasound

  2. Change from Baseline in submental circumference at 6 months

    Time frame: 6 months

    thickness of the submental fat measured by a tape measure

Secondary outcomes

  1. participants' assessment for improvement at 6 months

    Time frame: 6 months

    assessment for improvement by participants

  2. participants' assessment for satisfaction at 6 months

    Time frame: 6 months

    assessment for satisfaction by participants

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • Cutera Inc.

Registry information

Acronym: UNIRFFC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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