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

J

Jetema Co., Ltd.

Status

Completed

Conditions

Nasolabial Folds
Mid Face Volume Loss
Lip Volume Enhancement

Treatments

Device: Hyaluronic Acid (HA)

Study type

Observational

Funder types

Industry

Identifiers

NCT06699147
JT-D-OS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

238 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

238 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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