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

Multicenter, Prospective, Observational Study to Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S Applied to the Facial Region

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds; Lip Volume Enhancement; Mid Face Volume Loss
• Intervention / Treatment: Device: Hyaluronic Acid (HA)

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 Type: Observational
• Enrollment (Actual): 238

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Beauty Bar Clinics and 8 other clinics in South Korea

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nasolabial Folds; Wrinkle Severity Rating Scale(WSRS) assessed 3 or 4	Device: Hyaluronic Acid (HA); 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
Mid-Face Volume; Midface Volume Deficit Scale(MFVDS) assessed 3 or higher	Device: Hyaluronic Acid (HA); 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; Medicis Lip Fullness Scale(MLFS) assessed 1 or 2	Device: Hyaluronic Acid (HA); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement satisfaction assessment	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)	24 weeks

Collaborators and Investigators

• Sponsor: Jetema Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hyaluronic acid filler; facial region
• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: JT-D-OS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No