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OpenTrials
Completed

NCT Number: NCT05517824

Needle Radiofrequency Treatment for Submental Fat

The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale

Exclusion criteria

  • mental impairment, infectious disease
  • history of keloid development
  • pregnancy, pacemaker
  • use of anticoagulants
  • undergoing a facelift procedure within the prior 6 months.

Treatment and study plan

microinsulated needle radiofrequency

Procedure

A single treatment using a microinsulated needle radiofrequency device

Primary outcomes

  1. Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)

    Time frame: 1 month after the treatment

    submental fat rating by an independent investigator

Secondary outcomes

  1. submental fat volume (cc)

    Time frame: 1 month after the treatment

    fat volume quantified with a three-dimensional camera

  2. patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)

    Time frame: 1 month after the treatment

    patient's satisfaction score for reduction of submental fat

  3. any adverse effects at any time during or after treatment

    Time frame: assessed through study completion, an average of 2 months

    adverse events

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

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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