Lip Volume Enhancement, Mid Face Volume Loss, Nasolabial Folds
Conditions
Keywords
Hyaluronic acid filler, facial region
Brief summary
This study in multi-center, prospective and observational study. The purpose of this study is to observe effects and safety of hyaluronic acid filler series, eptq S and eptq Lidocaine S, for facial volume and folds.
Detailed description
Participants for this study are treated with eptq S and eptq Lidocaine S for smoothing nasolabial folds or volumizing mid-face or lips. Treating period is around 24 weeks. Facial volume and wrinkle condition, participants' satisfaction, and safety would be assessed.
Interventions
DEVICEHyaluronic Acid (HA)
6 types of hyaluronic acid(HA) fillers that are differ in HA concentration and lidocaine were used for this study. Each type was applied to different condition or group depending on the investigators medical diagnosis
Sponsors
Jetema Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and Female adults aged 19 years and older. * Meet one of the following among individuals who want temporary improvement of facial wrinkles and volume. 1. Wrinkle Severity Rating Scale score 3 or 4 for Nasolabial fold. 2. Mid-Face Volume Deficit Scale score 3 or greater. 3. Medicis Lip Fullness Scale score 1-2. In cases of 2-1) and 2-2), participants must meet both sides (right and left) to be eligible for enrollment. For 3), the Medicis Lip Fullness Scale scores 1-2 at the target sites for procedures (upper lip, lower lip, up & down) eligible for enrollment * Voluntarily agree to participate in this observational study in written consent form.
Exclusion criteria
* Received anti-thrombotics (except low-dose aspirin \[100 mg, maximum 300 mg/day\]) within 2 weeks from screening. * Currently have or have a history of bleeding disorder. * applied graft/prosthesis or biomaterials, including hyaluronic acid, polycaprolactone, collagen filler, lifting (threads, laser, etc.), and Botulinum toxin, at the site for indication within 24 weeks from screening. * Skin disorder or wound infection on the face that affects this study * Have history of side effects of EMLA cream or equivalent lidocaine agent. * History of hypersensitivity to hyaluronic acid agent(s). * Other contraindications as per the \[Precautions for Use\] in the approved label for the study device. * Determined as not eligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasolabial Folds | 24 weeks | Percentage(%) of subjects whose Wrinkle Severity Rating Scale was improved during follow-up period compared to the baseline (1: No visible fold - 5: Extremly deep fold) |
| Mid-Face Volume | 24 weeks | Percentage(%) of subjects whose Mid-face Volume Deficit Scale was improved during follow-up period compared to the base line (0: None - 5: Severe) |
| Lip Volume | 12 weeks | Percentage(%) of subjects whose Medicis Lip Fullness Scale was improved during follow-up period compared to the baseline (1: Very thin - 5: Very full) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement satisfaction assessment | 24 weeks | Percentage(%) of subjects whose Global Aesthetic Improvement Scale was improved during follow-up period compared to the base line (-1: Worse - 3: Very much improved) |
Countries
South Korea
Outcome results
None listed