Status:
NOT_YET_RECRUITING
Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.
Lead Sponsor:
Chang Chang Cheng
Collaborating Sponsors:
GRAND Medical Co., Ltd.
Conditions:
Facial Aging
Skin Laxity
Eligibility:
All Genders
20-60 years
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 ...
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 conti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06925074
Start Date
May 1 2025
End Date
April 1 2026
Last Update
April 13 2025
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taichung, Taiwan, 404