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

NCT06699147 | Completed

• 1 other identifier: JT-D-OS-001
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasolabial Folds; Mid Face Volume Loss; Lip Volume Enhancement

Keywords

Hyaluronic acid filler; facial region

Outcome Measures

Primary Outcomes (3)

• Nasolabial Folds

  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)

  24 weeks

• Mid-Face Volume

  Percentage(%) of subjects whose Mid-face Volume Deficit Scale was improved during follow-up period compared to the base line (0: None - 5: Severe)

  24 weeks

• Lip Volume

  Percentage(%) of subjects whose Medicis Lip Fullness Scale was improved during follow-up period compared to the baseline (1: Very thin - 5: Very full)

  12 weeks

Secondary Outcomes (1)

• Improvement satisfaction assessment

  24 weeks

Study Arms (3)

Nasolabial Folds

Wrinkle Severity Rating Scale(WSRS) assessed 3 or 4

Device: Hyaluronic Acid (HA)

Mid-Face Volume

Midface Volume Deficit Scale(MFVDS) assessed 3 or higher

Device: Hyaluronic Acid (HA)

Lip Volume

Medicis Lip Fullness Scale(MLFS) assessed 1 or 2

Device: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) DEVICE

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

Lip Volume; Mid-Face Volume; Nasolabial Folds

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Beauty Bar Clinics and 8 other clinics in South Korea

You may qualify if:

• 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 1-2. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jetema Co., Ltd.: lead

Study Sites (1)

Clinics

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 21, 2024
• Study Start: September 21, 2022
• Primary Completion: December 5, 2022
• Study Completion: May 6, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)