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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorChang Chang Cheng

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Men and women aged between 20 and 60.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Chang Cheng

Lead sponsor

China Medical University Hospital

Sponsor institution

GRAND Medical Co., Ltd.

Collaborator

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