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Facial AgingNCT06925074

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

An observational study of Facial Aging and Skin Laxity, run by Chang Chang Cheng at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Facial Aging, Skin Laxity, Cheek Wrinkles
How many people
15 participants
Where
1 siteTaiwan
Study dates
May 2025to Apr 2026
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Men and women aged between 20 and 60.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cheng Chang Chang contact

+886975681191

029279@tool.caaumed.org.tw

Taiwan1 site

  • China Medical University Hospital

    Taichung, Taichung, 404

    China Medical University Hospital, +8860422052121, N10807@mail.cmuh.org.tw

Other trials in Taiwan

About this study

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.

Read the 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.

Keywords
3D imaging, Skin laxity, Microwaves, Fat reduction, Facial aging
Medical subject headings
Cutis Laxa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At week 0, 4, 12

  5. Eyebrow-Orbital length

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

    Measured: At week 0, 4, 12

  6. Orbital-Upper Eyelid length

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

    Measured: At week 0, 4, 12

  7. 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.

    Measured: At week 0, 4, 12

  8. Eyebrow-Iris length

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

    Measured: At week 0, 4, 12

  9. Tragus-Oral length

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

    Measured: At week 0, 4, 12

  10. Lower Facial Contouring length

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

    Measured: At week 0, 4, 12

  11. 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.

    Measured: At week 0, 4, 12

  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.

    Measured: At week 0, 4, 12

Secondary outcomes (1)

  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.

    Measured: At week 0, 2, 4, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925074
Sponsor's protocol ID
CMUH114-REC2-040
Status last verified
Apr 2025
First submitted
6 Apr 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35778895

  • 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.

    PubMed 32996903

Questions about this trial

What is this clinical trial studying?

An observational study of Facial Aging and Skin Laxity, run by Chang Chang Cheng at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cheng Chang Chang (+886975681191, 029279@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eyebrow Peak angle (time frame: At week 0, 4, 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06925074, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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