Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S
NCT ID: NCT06699147
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
238 participants
OBSERVATIONAL
2022-09-21
2023-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Nasolabial Folds
Wrinkle Severity Rating Scale(WSRS) assessed 3 or 4
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
ALL
No
Sponsors
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Jetema Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Clinics
Seoul, , South Korea
Countries
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Other Identifiers
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JT-D-OS-001
Identifier Type: -
Identifier Source: org_study_id
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