Clinical trial NCT06925074: Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.
Official title: Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Facial Aging
Skin Laxity
Cheek Wrinkles
Keywords: 3D imaging
Skin laxity
Microwaves
Fat reduction
Facial aging
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: GRAND Medical Co., Ltd.
First posted: 2025-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged between 20 and 60.

Brief summary: 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.

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.

Eligibility criteria: 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 outcomes:
measure: Eyebrow Peak angle
timeFrame: At week 0, 4, 12
measure: Eyebrow Tail angle
timeFrame: At week 0, 4, 12
measure: Pupil-Eyebrow Peak angle
timeFrame: At week 0, 4, 12
measure: Canthus-Oral-Nasal angle
timeFrame: At week 0, 4, 12
measure: Eyebrow-Orbital length
timeFrame: At week 0, 4, 12
measure: Orbital-Upper Eyelid length
timeFrame: At week 0, 4, 12
measure: Vertical Palpebral Fissure length
timeFrame: At week 0, 4, 12
measure: Eyebrow-Iris length
timeFrame: At week 0, 4, 12
measure: Tragus-Oral length
timeFrame: At week 0, 4, 12
measure: Lower Facial Contouring length
timeFrame: At week 0, 4, 12
measure: Antiaging Scales for facial rejuvenation
timeFrame: At week 0, 4, 12
measure: LifeViz® Mini 3D imaging system
timeFrame: At week 0, 4, 12
Secondary outcomes:
measure: Global Aesthetic lmprovement Scale
timeFrame: At week 0, 2, 4, 12
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taichung
Study officials:
References:
citation: Salsi B, Fusco I. Non-invasive system delivering microwaves energy for unwanted fat reduction and submental skin tightening: Clinical evidence. J Cosmet Dermatol. 2022 Nov;21(11):5657-5664. doi: 10.1111/jocd.15205. Epub 2022 Jul 19.
citation: Spiroski M. Retraction: Five papers from Open Access Maced J Med Sci. Vol. 7 No. 18 (2019): Sep 30 (Global Dermatology). Open Access Maced J Med Sci. 2020 Sep 30;8(B):573. doi: 10.3889/oamjms.2020.5492.