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

About this trial

Last updated a year ago

Study ID

CMUH114-REC2-040

Status

Not yet recruiting

Type

Observational

Placebo

Accepting

20 to 60 Years

All Sexes

Trial Timing

Ended 2 months ago

What is this trial about?

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.

What are the participation requirements?

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.