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

Launched by JETEMA CO., LTD. · Nov 19, 2024

Keywords

ClinConnect Summary

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.

Gender

ALL

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.
• • 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.