Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.

N/ANot Yet RecruitingNCT06925074

Chang Chang Cheng15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Facial Aging Skin Laxity

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At week 0, 4, 12

Eyebrow-Orbital length

The linear distances from point superior orbital rim to the inferior border of eyebrow.

Time frame: At week 0, 4, 12

Orbital-Upper Eyelid length

The linear distances from point superior orbital rim to the superior border of palpebral fissure.

Time frame: 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.

Time frame: At week 0, 4, 12

Eyebrow-Iris length

The horizontal distance between the lateral limbus of the iris and the eyebrow peak .

Time frame: At week 0, 4, 12

Tragus-Oral length

The distances between the bilateral tragi passing through the oral commissure.

Time frame: At week 0, 4, 12

Lower Facial Contouring length

The distances between the bilateral tragi passing through the mental protuberance.

Time frame: 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.

Time frame: 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.

Time frame: At week 0, 4, 12

Secondary Outcomes

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. 1. Improved. Obvious improvement, but touch-up or re-treatment is indicated. 2. Much Improved. Marked improvement in the condition, but not optimal for the patient; a touch-up would slightly improve the outcome 3. Very much improved. Optimal cosmetic result for the patient.

Time frame: At week 0, 2, 4, 12

Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts