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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-treatment | Active Comparator | After a single treatment using a microinsulated needle RF device |
|
| Pre-treatment (Baseline) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microinsulated needle radiofrequency | Procedure | A single treatment using a microinsulated needle radiofrequency device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe) | submental fat rating by an independent investigator | 1 month after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| submental fat volume (cc) | fat volume quantified with a three-dimensional camera | 1 month after the treatment |
| patient satisfaction score from 0 (not satisfied) to 10 (most satisfied) | patient's satisfaction score for reduction of submental fat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Hun Huh | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36799883 | Derived | Kim BR, Kim M, Kim JW, Shin JW, Na JI, Huh CH. Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat. Dermatol Surg. 2023 Apr 1;49(4):389-394. doi: 10.1097/DSS.0000000000003723. Epub 2023 Feb 10. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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prospective, single-blinded, pre-post comparative study
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| 1 month after the treatment |
| any adverse effects at any time during or after treatment | adverse events | assessed through study completion, an average of 2 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |