Nasolabial FoldsNCT06699147
Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S
An observational study of Nasolabial Folds and Mid Face Volume Loss, run by Jetema Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nasolabial Folds, Mid Face Volume Loss, Lip Volume Enhancement
- What is being tested?
- Hyaluronic Acid (HA)
- Type of treatment
- Medical device
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2022to 6 May 2023
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Beauty Bar Clinics and 8 other clinics in South Korea
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Hyaluronic Acid (HA)
- Keywords
- Hyaluronic acid filler, facial region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Nasolabial Folds | Wrinkle Severity Rating Scale(WSRS) assessed 3 or 4 Receives: Device: Hyaluronic Acid (HA) | |
| Mid-Face Volume | Midface Volume Deficit Scale(MFVDS) assessed 3 or higher Receives: Device: Hyaluronic Acid (HA) | |
| Lip Volume | Medicis Lip Fullness Scale(MLFS) assessed 1 or 2 Receives: Device: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start21 Sep 2022
- Primary completion5 Dec 2022
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Jetema Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699147
- Sponsor's protocol ID
- JT-D-OS-001
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06699147
- Acronym / sponsor ID
- JT-D-OS-001
- Keywords
- Hyaluronic acid filler, facial region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Jetema Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasolabial Folds | – | Device: Hyaluronic Acid (HA)Wrinkle Severity Rating Scale(WSRS) assessed 3 or 4 |
| Mid-Face Volume | – | Device: Hyaluronic Acid (HA)Midface Volume Deficit Scale(MFVDS) assessed 3 or higher |
| Lip Volume | – | Device: Hyaluronic Acid (HA)Medicis Lip Fullness Scale(MLFS) assessed 1 or 2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Beauty Bar Clinics and 8 other clinics in South Korea
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Lip Volume, Mid-Face Volume, Nasolabial Folds |
Primary outcome
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)
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)
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)
1 secondary outcome
Improvement satisfaction assessment
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasolabial Folds and Mid Face Volume Loss, run by Jetema Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial Folds (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.