Nasolabial FoldsNCT03932045
A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds
A study testing SYB Filler (SF-01) and Ellansé M in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- SYB Filler (SF-01) and Ellansé M
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Oct 2018to 12 Aug 2022
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
- Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.
Who cannot join
- Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
- Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
- History of bleeding disorder in past or present
- Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
- Administered an hyaluronic acid filler within 24 weeks of the date of the screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Subject & Evaluator-blind, Matched Pairs, Prospective Study to Compare the Safety and Efficacy Between SYB Filler (SF-01) and Ellansé M in the Correction of Nasolabial Folds
The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.
- Conditions
- Nasolabial Folds
- Being tested
- SYB Filler (SF-01), Ellansé M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYB Filler (SF-01)Device
Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
Ellansé MDevice
Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
| Study group | Role | What they receive |
|---|---|---|
| SYB Filler (SF-01) | Experimental | PCL filler Receives: Device: SYB Filler (SF-01) |
| Ellansé M | Active comparator | PCL filler Receives: Device: Ellansé M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start8 Oct 2018
- Primary completion15 Sep 2020
- Study completion12 Aug 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Subject \& Evaluator-blind, Matched pairs, Prospective Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon KIM, M.D.,Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932045
- Sponsor's protocol ID
- SYB-SF01-301
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2019
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject & Evaluator-blind, Matched Pairs, Prospective Study to Compare the Safety and Efficacy Between SYB Filler (SF-01) and Ellansé M in the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03932045
- Acronym / sponsor ID
- SYB-SF01-301
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 30 Apr 2019 (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.
The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Subject \& Evaluator-blind, Matched pairs, Prospective Study
| Arm | Type | Receives |
|---|---|---|
| SYB Filler (SF-01) | Experimental | Device: SYB Filler (SF-01)PCL filler |
| Ellansé M | Active comparator | Device: Ellansé MPCL filler |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
- Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.
Key exclusion criteria (5 listed)
- Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
- Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
- History of bleeding disorder in past or present
- Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
- Administered an hyaluronic acid filler within 24 weeks of the date of the screening
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 |
|---|---|---|
| SYB Filler (SF-01)Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold. | Device | SYB Filler (SF-01) |
| Ellansé MApply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold. | Device | Ellansé M |
Primary outcome
Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed
Time frame: 12months
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
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 22 Nov 2022.
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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.
Beom Joon KIM, M.D.,Ph.D. principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYB Filler (SF-01) and Ellansé M in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation 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 2 inclusion and 5 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 22 Nov 2022. 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?
Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed (time frame: 12months). 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 22 Nov 2022.