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

NCT06925074 | Not Yet Recruiting

• 1 other identifier: CMUH114-REC2-040
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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. 1.How effective is the microwave-based system in reducing fat and tightening Skin?
2. 2.What objective methods can be used to measure treatment outcomes?
3. 3.What are the optimal treatment parameters for maximum efficacy?
4. 4.What are the safety and side effects associated with the treatment?
5. 5.How long-lasting are the results?

Conditions

Facial Aging; Skin Laxity; Cheek Wrinkles

Keywords

3D imaging; Skin laxity; Microwaves; Fat reduction; Facial aging

Outcome Measures

Primary Outcomes (12)

• 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.

  At week 0, 4, 12

• 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.

  At week 0, 4, 12

• Pupil-Eyebrow Peak angle

  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

  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

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

  At week 0, 4, 12

• Orbital-Upper Eyelid length

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

  At week 0, 4, 12

• 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.

  At week 0, 4, 12

• Eyebrow-Iris length

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

  At week 0, 4, 12

• Tragus-Oral length

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

  At week 0, 4, 12

• Lower Facial Contouring length

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

  At week 0, 4, 12

• 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.

  At week 0, 4, 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.

  At week 0, 4, 12

Secondary Outcomes (1)

• Global Aesthetic lmprovement Scale

  At week 0, 2, 4, 12

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged between 20 and 60.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Chang Cheng: lead
• GRAND Medical Co., Ltd.: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taichung, 404, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 35778895 BACKGROUND

• 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.

  PMID: 32996903 BACKGROUND

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Cheng Chang Chang

CONTACT

+886975681191; 029279@tool.caaumed.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

TW (1)