Needle Radiofrequency Treatment for Submental Fat
Not Applicable
Completed
- Conditions
- Obese
- Interventions
- Procedure: microinsulated needle radiofrequency
- Registration Number
- NCT05517824
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Post-treatment microinsulated needle radiofrequency After a single treatment using a microinsulated needle RF device
- Primary Outcome Measures
Name Time Method Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe) 1 month after the treatment submental fat rating by an independent investigator
- Secondary Outcome Measures
Name Time Method submental fat volume (cc) 1 month after the treatment fat volume quantified with a three-dimensional camera
patient satisfaction score from 0 (not satisfied) to 10 (most satisfied) 1 month after the treatment patient's satisfaction score for reduction of submental fat
any adverse effects at any time during or after treatment assessed through study completion, an average of 2 months adverse events
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of