Multicenter, Prospective, Observational Study to Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S Applied to the Facial Region
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Nasolabial Folds
- Sponsor
- Jetema Co., Ltd.
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Nasolabial Folds
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
- •Wrinkle Severity Rating Scale score 3 or 4 for Nasolabial fold.
- •Mid-Face Volume Deficit Scale score 3 or greater.
- •Medicis Lip Fullness Scale score 1-
- •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.
Outcomes
Primary Outcomes
Nasolabial Folds
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Improvement satisfaction assessment(24 weeks)