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OpenTrials
Completed

NCT Number: NCT06699147

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinics

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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.

Treatment and study plan

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

Primary outcomes

  1. Nasolabial Folds

    Time frame: 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)

  2. Mid-Face Volume

    Time frame: 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)

  3. Lip Volume

    Time frame: 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 outcomes

  1. Improvement satisfaction assessment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Jetema Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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