None listed
Conditions
Interventions
Medical Device : The test device and control device of this clinical trial are used in the same way.
Randomly assigned medical devices are applied subcutaneously on both sides of the face, 2 to 6 cc p
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 30 and 65 2) Those who need correction of mid-face volume deficit scale (MFVDS) grade 2 or higher facial volume 3) Those whose face volume is bilaterally symmetrical 4) Those who agreed not to undergo other facial correction procedures during the clinical trial period 5) A person who is willing to participate in a clinical trial, comply with treatment and procedures, and visit a hospital for all observation evaluations 6) A person who voluntarily signed a written consent after hearing the explanation about the purpose and method of this clinical trial
Exclusion criteria
Exclusion criteria: 1) Those who have taken anticoagulants within 2 weeks before participating in the clinical trial (however, low-dose (300 mg/day or less) aspirin administration is allowed.) 2) Those who have applied calcium hydroxyapatite (CaHA) to the target area of this study within 1 year before participating in the clinical trial 3) Those who administer immunosuppressants 4) Those who have undergone permanent filler treatment or fat grafting in the area subject to this study 5) Those who have undergone wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, middle skin peel, dermal photorejuvenation, etc.) within 6 months prior to participation in the clinical trial 6) Those with a history of hypersensitivity to lidocaine or hyaluronic acid 7) Those with a history of keloid formation or hypertrophic scars on the face 8) Those with a history of streptococcal infectious disease on the face 9) Subjects with wounds, scars, skin disorders or infections around the area subject to this study that may affect efficacy evaluation 10) If those are pregnant or lactating, or if those are a woman of childbearing age, those do not agree to maintain contraception during the clinical trial period (*Medically accepted contraception methods: use condoms, oral contraception continued for at least 3 months, or injection or insertion contraceptives) If those do, if those have an intrauterine contraceptive device installed, etc.) 11) Those who participated in clinical trials of other drugs or medical devices within 4 weeks of screening and received drugs or applied medical devices 12) Those who are judged inappropriate to participate in the test by other testers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of improvement of 1 or more in MFVDS compared to baseline score | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of improvement of 1 or more in MFVDS compared to baseline score;Changes in MFVDS compared to baseline score;Percentage of improvement on the global aesthetic improvement scale (GAIS) assessed by the operator;Operator's satisfaction;GAIS improvement rate as assessed by subjects;Pain level of the subject(visual analogue scale, VAS) | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Hyoung Kim
Pusan National University
Outcome results
None listed