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| Name | Class |
|---|---|
| GRAND Medical Co., Ltd. | UNKNOWN |
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The goal of this observational study is to evaluate the effectiveness and safety of microwave-assisted heating technology in facial fat reduction and skin tightening in Asians.
The main questions it aims to answer are:
Participants will go through three treatment sessions using the "DEKA" ONDA Microwave treatment system, with each session lasting 12 minutes.
As people age, facial skin sagging and submental fat accumulation have become concerns for many, not only affecting their appearance but also negatively impacting their self-confidence. With the continuous advancement of modern medical aesthetic technology, noninvasive treatments like microwave-assisted heating technology have provided new solutions for addressing these issues.
The microwave-assisted heating technology works by precisely heating subcutaneous fat tissue with high-frequency energy, inducing fat cell apoptosis while simultaneously stimulating collagen production in the skin, thereby achieving fat reduction and skin tightening. Compared to traditional surgical methods, this technique offers the advantages of being non-invasive, having a short recovery period, and carrying lower risks.
To further investigate these effects, we plan to conduct a prospective, open-label clinical trial. The treatment will focus on enhancing the mid and lower facial area, while carefully managing the treatment time and monitoring patient comfort.
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| Measure | Description | Time Frame |
|---|---|---|
| Eyebrow Peak angle | The vertices of the Eyebrow Peak angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground. | At week 0, 4, 12 |
| Eyebrow Tail angle | The vertices of the Eyebrow Tail angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground. | At week 0, 4, 12 |
| Pupil-Eyebrow Peak angle | The Pupil-Eyebrow Peak angle is then measured between this line and another line connecting nasal to eyebrow peak. | At week 0, 4, 12 |
| Canthus-Oral-Nasal angle | The Canthus-Oral-Nasal angle is measured between a line connecting oral commissure to nasal and a line connecting oral commissure to lateral canthus. | At week 0, 4, 12 |
| Eyebrow-Orbital length | The linear distances from point superior orbital rim to the inferior border of eyebrow. | At week 0, 4, 12 |
| Orbital-Upper Eyelid length | The linear distances from point superior orbital rim to the superior border of palpebral fissure. | At week 0, 4, 12 |
| Vertical Palpebral Fissure length | The size of the palpebral fissure can be determined by measuring the vertical distance between the superior and inferior borders of palpebral fissure when the eyes are at rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic lmprovement Scale | -1: Worse. Appearance worse than the original condition or with complications. 0: No change. Appearance essentially the same as the original condition.
|
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Inclusion Criteria:
Exclusion Criteria:
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Men and women aged between 20 and 60.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Chang Chang | Contact | +886975681191 | 029279@tool.caaumed.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taichung | 404 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35778895 | Background | Salsi B, Fusco I. Non-invasive system delivering microwaves energy for unwanted fat reduction and submental skin tightening: Clinical evidence. J Cosmet Dermatol. 2022 Nov;21(11):5657-5664. doi: 10.1111/jocd.15205. Epub 2022 Jul 19. | |
| 32996903 | Background | Spiroski M. Retraction: Five papers from Open Access Maced J Med Sci. Vol. 7 No. 18 (2019): Sep 30 (Global Dermatology). Open Access Maced J Med Sci. 2020 Sep 30;8(B):573. doi: 10.3889/oamjms.2020.5492. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| At week 0, 4, 12 |
| Eyebrow-Iris length | The horizontal distance between the lateral limbus of the iris and the eyebrow peak . | At week 0, 4, 12 |
| Tragus-Oral length | The distances between the bilateral tragi passing through the oral commissure. | At week 0, 4, 12 |
| Lower Facial Contouring length | The distances between the bilateral tragi passing through the mental protuberance. | At week 0, 4, 12 |
| Antiaging Scales for facial rejuvenation | A table that shows the antiaging scale system utilizing the 4 angular and 6 linear measurements described above. Index 5 is identified as "neutral" or "no significant changes". Total score for the whole face was 100; either lower or higher than 50 suggesting "aging" or "rejuvenation, respectively". °: degree; mm: millimeter. | At week 0, 4, 12 |
| LifeViz® Mini 3D imaging system | This 3D photographic system can be used to calculate the differences in volume in a treated area precisely and accurately for professional patient follow-up. | At week 0, 4, 12 |
| At week 0, 2, 4, 12 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |