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

Completed

• Conditions: Nasolabial Folds; Mid Face Volume Loss; Lip Volume Enhancement

• Registration Number: NCT06699147
• Lead Sponsor: Jetema Co., Ltd.

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.

Study Timeline

• Study Start: 2022-09-21
• Primary Completion: 2022-12-05
• Study Completion: 2023-05-06
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Clinics; 🇰🇷 Seoul, Korea, Republic of