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

April 6, 2025 updated by: Chang Chang Cheng

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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 (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taichung
      • Taichung City, Taichung, Taiwan, 404
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Men and women aged between 20 and 60.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyebrow Peak angle
Time Frame: 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.
At week 0, 4, 12
Eyebrow Tail angle
Time Frame: 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.
At week 0, 4, 12
Pupil-Eyebrow Peak angle
Time Frame: At week 0, 4, 12
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
Time Frame: 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.
At week 0, 4, 12
Eyebrow-Orbital length
Time Frame: At week 0, 4, 12
The linear distances from point superior orbital rim to the inferior border of eyebrow.
At week 0, 4, 12
Orbital-Upper Eyelid length
Time Frame: At week 0, 4, 12
The linear distances from point superior orbital rim to the superior border of palpebral fissure.
At week 0, 4, 12
Vertical Palpebral Fissure length
Time Frame: 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.
At week 0, 4, 12
Eyebrow-Iris length
Time Frame: At week 0, 4, 12
The horizontal distance between the lateral limbus of the iris and the eyebrow peak .
At week 0, 4, 12
Tragus-Oral length
Time Frame: At week 0, 4, 12
The distances between the bilateral tragi passing through the oral commissure.
At week 0, 4, 12
Lower Facial Contouring length
Time Frame: At week 0, 4, 12
The distances between the bilateral tragi passing through the mental protuberance.
At week 0, 4, 12
Antiaging Scales for facial rejuvenation
Time Frame: 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.
At week 0, 4, 12
LifeViz® Mini 3D imaging system
Time Frame: 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.
At week 0, 4, 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic lmprovement Scale
Time Frame: At week 0, 2, 4, 12

-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.
At week 0, 2, 4, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Chang Cheng

Collaborators

GRAND Medical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH114-REC2-040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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