Nasolabial FoldsNCT06295172
A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement
A study testing Lafullen15 and Lafullen in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation.
Trial summary
The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Lafullen15 and Lafullen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2024to 30 Apr 2026
- 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 19 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
No sites are listed yet.
About this study
Official title: A Randomized, Evaluator-blind, Matched Pairs, Prospective, Non Inferiority, Confirmatory Study to Compare the Safety and Efficacy Between Lafullen15 and Lafullen in the Correction of Nasolabial Folds
The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds
- Conditions
- Nasolabial Folds
- Being tested
- Lafullen15, Lafullen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lafullen15Device
Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen).
LafullenDevice
Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen).
| Study group | Role | What they receive |
|---|---|---|
| Lafullen15 | Experimental | PCL filler Receives: Device: Lafullen15 |
| Lafullen | Active comparator | PCL filler Receives: Device: Lafullen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator
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 posted6 Mar 2024
- Study start27 May 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
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, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jongho KIM, M.D.,Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295172
- Sponsor's protocol ID
- LF15_NLF_301
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blind, Matched Pairs, Prospective, Non Inferiority, Confirmatory Study to Compare the Safety and Efficacy Between Lafullen15 and Lafullen in the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06295172
- Acronym / sponsor ID
- LF15_NLF_301
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Mar 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.
The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study
| Arm | Type | Receives |
|---|---|---|
| Lafullen15 | Experimental | Device: Lafullen15PCL filler |
| Lafullen | Active comparator | Device: LafullenPCL filler |
Who may qualify
- Ages
- 19 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 |
|---|---|---|
| Lafullen15Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen). | Device | Lafullen15 |
| LafullenApply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen). | Device | Lafullen |
Primary outcome
Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
Jongho KIM, M.D.,Ph.D. principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lafullen15 and Lafullen in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation.
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: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gyeongsoon Kim (+82-2-2157-9851, gyeongsoon.kim@samyang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator (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 14 May 2024.