Obese
Conditions
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.
Interventions
PROCEDUREmicroinsulated needle radiofrequency
A single treatment using a microinsulated needle radiofrequency device
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
prospective, single-blinded, pre-post comparative study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed