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:
1. How effective is the microwave-based system in reducing fat and tightening Skin?
2. What objective methods can be used to measure treatment outcomes?
3. What are the optimal treatment parameters for maximum efficacy?
4. What are the safety and side effects associated with the treatment?
5. How long-lasting are the results?
Participants will go through three treatment sessions using the "DEKA" ONDA Microwave treatment system, with each session lasting 12 minutes.
Eligibility
Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Men and women aged between 20 and 60.
* Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
* Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Exclusion Criteria:
* Subjects with autoimmune diseases/received immunotherapy and subjects with diabetes mellitus.
* Subjects with a history of a hypertrophic scar.
* Pregnant or breastfeeding women.
* Subjects with untreated epilepsy or underlying porphyria.
* When there is an active disease (such as inflammation, infection or tumors) in or near the intended treatment site.
* Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, facial lift, facial peels, excisional facial surgery, dermal photorejuvenation, oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months before screening as determined by the Principal Investigator.
* The subject who received soft tissue augmentation at the treatment site at any time before screening as determined by the Principal Investigator.
* Subjects with a scar or skin lesion at the treatment site that may interfere with the judgment of the treatment effect.
* Subjects who participated in another clinical trial within 60 days before screening or plan to participate in another investigation during this study.
* Subjects who plan to receive other wrinkle improvement treatments in the face during this trial.
* Subjects who are otherwise determined by the investigator as ineligible for this study.
Primary outcome measure(s)
Eyebrow Peak angle — At week 0, 4, 12 The vertices of the Eyebrow Peak angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Eyebrow Tail angle — At week 0, 4, 12 The vertices of the Eyebrow Tail angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Pupil-Eyebrow Peak angle — At week 0, 4, 12 The Pupil-Eyebrow Peak angle is then measured between this line and another line connecting nasal to eyebrow peak.
Canthus-Oral-Nasal angle — At week 0, 4, 12 The Canthus-Oral-Nasal angle is measured between a line connecting oral commissure to nasal and a line connecting oral commissure to lateral canthus.
Eyebrow-Orbital length — At week 0, 4, 12 The linear distances from point superior orbital rim to the inferior border of eyebrow.
Orbital-Upper Eyelid length — At week 0, 4, 12 The linear distances from point superior orbital rim to the superior border of palpebral fissure.
Vertical Palpebral Fissure length — At week 0, 4, 12 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.
Eyebrow-Iris length — At week 0, 4, 12 The horizontal distance between the lateral limbus of the iris and the eyebrow peak .
Tragus-Oral length — At week 0, 4, 12 The distances between the bilateral tragi passing through the oral commissure.
Lower Facial Contouring length — At week 0, 4, 12 The distances between the bilateral tragi passing through the mental protuberance.
Antiaging Scales for facial rejuvenation — At week 0, 4, 12 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.
LifeViz® Mini 3D imaging system — At week 0, 4, 12 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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