Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S

Jetema Co., Ltd.

Status

Completed

Conditions

Nasolabial Folds

Mid Face Volume Loss

Lip Volume Enhancement

Treatments

Device: Hyaluronic Acid (HA)

Study type

Observational

Funder types

Industry

Identifiers

NCT06699147

JT-D-OS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

238 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.