None listed
Conditions
Interventions
Medical Device : The device is applied subcutaneously and on the periosteum in the zygomaticomalar region, anteromedial cheek, and submalar region of the central part of the face. The application area
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals wishing to undergo filler treatments for temporary volume augmentation in the midface due to volume reduction, which is evaluated as grade 3 or higher in bilateral symmetry according to the investigator's field evaluation for clinical trial medical devices in areas including the central face, zygomaticomalar region, anteromedial cheek, and submalar region. 2. Individuals who agree not to receive fillers, botulinum toxin, laser treatment, chemical peels, or cosmetic surgeries outside of this clinical trial in the central face during the trial participation period. 3. Individuals who have listened to an explanation of the purpose, methods, and efficacy of the clinical trial and have signed the written consent form.
Exclusion criteria
Exclusion criteria: A. Those who have received anticoagulant therapy or antiplatelet therapy within 10 days prior to the application of the clinical trial medical device or are expected to require administration within 3 days after the application of the clinical trial medical device [e.g., patients with atrial fibrillation (A fib) who are expected to have an increased risk of cardio-cerebral events upon stopping antithrombotic therapy at the investigator's discretion, provided that participation in the clinical trial is possible after a 10-day washout period from existing anticoagulant or antiplatelet therapy]. B. Individuals with the following procedural history before the screening visit - facial surgery for cosmetic purposes (excluding rhinoplasty performed more than 2 years ago), tissue grafting, and those who have undergone tissue augmentation using implants (e.g., silicone, fat, sclerosing gel, permanent/semi-permanent fillers such as hydroxyethylmethacrylate (HEMA), dextran (DEAE), polylactic acid (PLA), etc.). C. Individuals who participated in another clinical trial and received clinical trial drugs or used clinical trial medical devices within the last 4 weeks before participating in this trial. H. Individuals with a history of anaphylaxis or severe complex allergies. I. Individuals who have clinically significant impairment in the cardiovascular, digestive, respiratory, endocrine, or central nervous systems, or who have had or currently have mental disorders that may significantly affect this clinical trial. J. Any other individuals deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 weeks after application of the investigational medical device, an independent photographic evaluator dies Improvement according to overall MFVDS as assessed by zine Proportion of study subjects defined as | — |
Secondary
| Measure | Time frame |
|---|---|
| At 24 weeks after application of the investigational medical device, an independent photo evaluator Improvement according to overall MFVDS as assessed by photographs Proportion of study subjects defined as | — |
Countries
Korea, Republic of
Contacts
Public ContactKui young Park
Chung-Ang Univerisity Hospital
Outcome results
None listed