Nasolabial Fold CorrectionNCT06961448
A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds
A study testing Hyaluronate Gel for Injection and Polycaprolactone microsphere filler in people with Nasolabial Fold Correction, run by Samyang Biopharmaceuticals Corporation.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Fold Correction
- What is being tested?
- Hyaluronate Gel for Injection and Polycaprolactone microsphere filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or above, with no gender restriction.
- Willing to receive treatment for correcting nasolabial fold.
- Treatment investigator evaluate those with a WSRS score of 3 or 4 for bilateral nasolabial folds;
- Willing to voluntarily participate in the clinical trial, accepting the obligation not toreceive all plastic surgery and cosmetic dermatology procedures or treatments during the trial。 Willing and able to undergo the required treatment and follow-up observations, and sign the informed consent form.
Who cannot join
- Allergy to polycaprolactone, hyaluronic acid products or any component of the investigational device or control device(such as streptococcal proteins), allergy to any local anesthetic (such as lidocaine or other amide-typeanesthetic), or history of severe allergic reactions and multiple severe allergic reactions.
- Previous surgery, cosmetic facial procedure, or plans to undergo cosmetic surgery in NLF area or lower face during the trial, inculding any of the following circumstances:
- Received permanent fillers or prostheses (such as PMMA etc.) or semi-permanent dermal fillers (such as CaHA, PLLA, PCL, etc.).
- Received temporary dermal fillers (such as HA and collagen etc.) within 12 months prior to screening.
- Received anti-wrinkle surgery within 12 months prior to screening.
- Receiving botulinum toxin injection, chemical stripping, radiofrequency laser, and liquid nitrogen freezing anti-wrinkle treatment within 6 months.
Show all 21Show fewer
- Individuals who used topical agents (e.g., corticosteroids, steroids [excluding hydrocortisone], retinoids, or retinoid derivatives intended as medications but not as cosmetics) on the mid-to-lower facial area within 3 months prior to screening or plan to use them during the trial period, as well as those undergoing hydrocortisone treatment.
- Individuals with abnormal coagulation mechanisms [activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal (ULN), etc.], or use of anticoagulants (e.g., warfarin, rivaroxaban), antiplatelet agents (e.g., aspirin, clopidogrel), thrombolytic agents (e.g., recombinant human urokinase) within 2 weeks prior to screening.
- Individuals with severe liver or kidney dysfunction, such as liver function markers (ALT, AST) exceeding 2 times the ULN or kidney function markers (creatinine) exceeding 1.5 times the ULN.
- Individuals with infectious diseases, including any positive test results for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies.
- Individuals with scars, unhealed wounds, deformities, defects, tattoos, or excessive pigmentation in the nasolabial fold area that may affect the efficacy assessment.
- Individuals with tumors, precancerous lesions, active skin lesions such as herpes, in the nasolabial fold area.
- Individuals with acute or chronic skin diseases such as infections or inflammation in the treatment area.
- Individuals with autoimmune diseases, such as psoriasis.
- Individuals with uncontrolled diabetets.
- Individuals prone to scarring, keloid formation, or hypertrophic scars.
- Individuals diagnosed with psychiatric disorders, lacking self-autonomy, or experiencing active episodes of anxiety or depression.
- Individuals with excessively high expectations of treatment outcomes or unwilling to accept potential short-term side effects such as bruising, swelling, or pain.
- Individuals who are pregnant, breastfeeding, or unwilling to use medically approved contraception (e.g., oral contraceptives, condoms, intrauterine devices) during the trial.
- Individuals who participated in other drug or medical device clinical trials within 3 months prior to screening.
- Individuals deemed unsuitable for trial participation by the investigator for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multi-center, Evaluator-blinded, Randomized, Parallel-controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Polycaprolactone Microsphere Fillers for Correction of Moderate to Severe Nasolabial Folds
The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender.
The main questions it aims to answer are:
Read more
- Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)?
- Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection.
Participants will:
- Receive either Lafullen or Restylane via injection in the nasolabial fold area.
- Optionally receive a touch-up injection at 4 weeks after the first treatment if needed.
- Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment.
- Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety.
- Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).
- Conditions
- Nasolabial Fold Correction
- Being tested
- Hyaluronate Gel for Injection, Polycaprolactone microsphere filler
- Keywords
- Polycaprolactone microsphere filler, Nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronate Gel for InjectionDevice
Apply a maximum of 1.5 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.
Polycaprolactone microsphere fillerDevice
Apply a maximum of 1.0 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronate Gel for Injection | Active comparator | HA filler Receives: Device: Hyaluronate Gel for Injection |
| Lafullen | Experimental | PCL filler Receives: Device: Polycaprolactone microsphere filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS Responder Rate at Week 48
Wrinkle Severity Rating Scale (WSRS) responder rate: Percentage of participants showing ≥1-point improvement from baseline in WSRS on both sides of the nasolabial folds, as evaluated by a blinded assessor using standardized facial photographs. A higher percentage indicates greater wrinkle correction efficacy.
Measured: 48 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold CorrectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hangzhou Inshow Biotechnology Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961448
- Sponsor's protocol ID
- LF30_NLF_China
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not been finalized. While we recognize the potential value of IPD sharing for further scientific research and transparency, we must first evaluate internal policies, data protection regulations, and ethical considerations regarding participant privacy before determining a final plan.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Evaluator-blinded, Randomized, Parallel-controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Polycaprolactone Microsphere Fillers for Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06961448
- Acronym / sponsor ID
- LF30_NLF_China
- Conditions
- Nasolabial Fold Correction
- Keywords
- Polycaprolactone microsphere filler, Nasolabial folds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Hangzhou Inshow Biotechnology Co.,Ltd.
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 May 2025 (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 goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender.
The main questions it aims to answer are:
- Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)?
- Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection.
Participants will:
- Receive either Lafullen or Restylane via injection in the nasolabial fold area.
- Optionally receive a touch-up injection at 4 weeks after the first treatment if needed.
- Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment.
- Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety.
- Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronate Gel for Injection | Active comparator | Device: Hyaluronate Gel for InjectionHA filler |
| Lafullen | Experimental | Device: Polycaprolactone microsphere fillerPCL filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or above, with no gender restriction.
- Willing to receive treatment for correcting nasolabial fold.
- Treatment investigator evaluate those with a WSRS score of 3 or 4 for bilateral nasolabial folds;
- Willing to voluntarily participate in the clinical trial, accepting the obligation not toreceive all plastic surgery and cosmetic dermatology procedures or treatments during the trial。 Willing and able to undergo the required treatment and follow-up observations, and sign the informed consent form.
Key exclusion criteria (21 listed)
- Allergy to polycaprolactone, hyaluronic acid products or any component of the investigational device or control device(such as streptococcal proteins), allergy to any local anesthetic (such as lidocaine or other amide-typeanesthetic), or history of severe allergic reactions and multiple severe allergic reactions.
- Previous surgery, cosmetic facial procedure, or plans to undergo cosmetic surgery in NLF area or lower face during the trial, inculding any of the following circumstances:
- Individuals who used topical agents (e.g., corticosteroids, steroids [excluding hydrocortisone], retinoids, or retinoid derivatives intended as medications but not as cosmetics) on the mid-to-lower facial area within 3 months prior to screening or plan to use them during the trial period, as well as those undergoing hydrocortisone treatment.
- Individuals with abnormal coagulation mechanisms [activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal (ULN), etc.], or use of anticoagulants (e.g., warfarin, rivaroxaban), antiplatelet agents (e.g., aspirin, clopidogrel), thrombolytic agents (e.g., recombinant human urokinase) within 2 weeks prior to screening.
- Individuals with severe liver or kidney dysfunction, such as liver function markers (ALT, AST) exceeding 2 times the ULN or kidney function markers (creatinine) exceeding 1.5 times the ULN.
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 |
|---|---|---|
| Hyaluronate Gel for InjectionApply a maximum of 1.5 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment. | Device | Hyaluronate Gel for Injection |
| Polycaprolactone microsphere fillerApply a maximum of 1.0 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment. | Device | Lafullen |
Primary outcome
WSRS Responder Rate at Week 48
Time frame: 48 weeks after injection
Wrinkle Severity Rating Scale (WSRS) responder rate: Percentage of participants showing ≥1-point improvement from baseline in WSRS on both sides of the nasolabial folds, as evaluated by a blinded assessor using standardized facial photographs. A higher percentage indicates greater wrinkle correction efficacy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not been finalized. While we recognize the potential value of IPD sharing for further scientific research and transparency, we must first evaluate internal policies, data protection regulations, and ethical considerations regarding participant privacy before determining a final plan.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronate Gel for Injection and Polycaprolactone microsphere filler in people with Nasolabial Fold Correction, 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 4 inclusion and 21 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: opening soon, as of the sponsor's last update on 8 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joong-won Park (+82-2-2157-9852, joongwon.park@samyang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WSRS Responder Rate at Week 48 (time frame: 48 weeks after injection). 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 8 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.