Wrinkles Such as Nasolabial FoldsNCT05040594
Evaluate the Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Filler in the Treatment of Nasolabial Folds.
A study testing PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine in people with Wrinkles Such as Nasolabial Folds, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PavéDerm J-fill soft dermal filler vs. Restylane® Lyft lidocaine in the treatment of moderate to severe nasolabial folds. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles Such as Nasolabial Folds
- What is being tested?
- PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Dec 2019to 5 Nov 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 and 70.
- Subjects who want to improve bilateral nasolabial folds that are rated as 3 or 4 grades on the WSRS, and same WSRS scores on both sides (both sides are grade 3 or 4 on the WSRS).
- Subjects with visually symmetrical bilateral nasolabial folds.
- Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
- Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Who cannot join
- Subjects who received an anticoagulant, thrombolytic, antiplatelet therapy or other substances are knownto increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba), or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 2 weeks prior to screening.
- -Except for low-dose aspirin (100 mg, up to 300 mg/day) or equivalent.
- Subjects who received/used a prohibited treatment/procedure as following:
- Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, face lift, facial peels, excisional facial surgery, dermal photorejuvenation clinically significant oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months prior to screening as determined by the Principal Investigator.
- Prescription strength topical retinoids or other topical anti-wrinkle or acne therapies that may interfere with the treatment area or evaluation within 2 weeks prior to screeningas determined by the Principal Investigator.
- Any oral other anti-wrinkle or acne therapies that may interfere with the treatment area or evaluation within 4 weeks prior to screening as determined by the Principal Investigator.
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- Subjects who received high dose vitamin E (e.g., 400 IU), corticosteroids, or interferon that may interfere with the treatment area or evaluation within 4 weeks prior to screening.
- The subject who received soft tissue augmentation as following at the investigational medical device injection site within a certain time frame prior to screening:
- -Previous 6 months with bovine collagen; previous 12 months with porcine or human collagen; previous 18 months with hyaluronic acid or hydroxyapatite.
- The subject who received soft tissue augmentation near the injection site with any of the following at any time:
- -Autologous fat, polymethylmethacrylate or other acrylates, polyacrylamide, polyethylene oxide, polylactic acid, permanent expander prosthesis (e.g., soft-form or silicon), or other implant materials.
- Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with the judgment of the treatment effect.
- Subjects with a history of anaphylaxis or history or presence of multiple severe allergies, allergy to lidocaine or other amide-type anesthetics, hyaluronic acid products, or any component of devices.
- The subject is, in the Investigator's opinion, at an undue risk based on the precautions, warnings, and contraindications for local lidocaine anesthetics.
- Subjects with a history of a hypertrophic scar, keloid, or clinically significant skin pigmentation disorders.
- Subjects with a skin disease or wound infection at the investigational medical device injection site.
- Subjects who participated in another clinical trial within 60 days prior to screening or plan to participate in another investigation during the course of this study.
- Pregnant or breastfeeding women or women of childbearing potential who have a plan to get pregnant during the study period, or are not using medically acceptable contraception or not consenting to practice birth control from screening until 30 days after the study has ended (last study procedure).
- Medically acceptable methods of contraception: non-hormonal intrauterine device or double barrier method (e.g., condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence can be used as a method of contraception.
- Be surgically sterile for at least 6 months and/or Post-menopausal for at least 1 year are not considered as women with childbearing potential.
- History of autoimmune diseases/connective tissue disease, or currently suffer from autoimmune disease/connective tissue disease (e.g., rheumatoid arthritis, Crohn's disease, systemic lupus erythematosus, polymyositis (PM), dermatomyositis (DM) or scleroderma.)
- Subjects with poorly controlled diabetes mellitus (e.g., an uninterrupted HbA1c >8.0% for ≥1 year despite standard care, are at high risk for complications; standard care with three oral glucose-lowering medications).
- Subjects with epilepsy, which is not controlled by anti-epilepsy therapy.
- Subjects with underlying porphyria.
- Subjects with underlying bleeding disorders.
- History of malignancy within the past 5 years.
- Subjects who plan to receive other wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial.
- Subjects with underlying systematic diseases (e.g., cardiovascular, digestive, respiratory, endocrine, central nervous system disorders that seems clinically significant), active skin disease or inflammation on or near nasolabial folds that, in the Principal Investigator's opinion, may interfere with treatment area and/or study assessments.
- Subjects who are otherwise determined by the investigator as ineligible for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy and Safety of PavéDerm J-Fill Soft Dermal Filler vs. Restylane® Lyft Lidocaine in the Treatment of Moderate to Severe Nasolabial Folds.
The purpose of this study is to evaluate the efficacy and safety of PavéDerm J-fill soft dermal filler vs. Restylane® Lyft lidocaine in the treatment of moderate to severe nasolabial folds.
Read the detailed description
This is a single-center, subject and evaluator blinded, intra-individual, split-face controlled clinical trial. After subjects voluntarily give written consent to the participation in the study, his/her eligibility for the study will be judged through demographic and past \& medication history investigation and laboratory test.
Subjects eligible in the screening will be enrolled. Each patient will receive PavéDerm J-Fill Soft Dermal Filler in one nasolabial fold and Restylane Lyft Lidocaine (20 mg/mL Hyaluronic acid with 3 mg/ml Lidocaine hydrochloride) in the other by randomization.
The faces of all subjects are going to be digitally photographed at rest upon every visit. The identical ambient conditions will be used for all photographs and assessments. To ensure blinding status, the subjects will be put on eye mask during injection. On injection day, subjects will receive injections, with at least 60 minute apart, to each nasolabial fold by the treating investigator. The amount of injection will be determined according to the width, length, and depth of the nasolabial folds to ensure optimal correction for each subject. The injected volume will not exceed 1.0 mL in ipsilateral nasolabial fold. The relevant information associated with the injection of the investigational medical device will be documented.
After each injection, the treating investigator will observe subjects through 30 minutes for assessment of adverse events. Subjects will be asked about adverse events at each follow-up visit, and any adverse events will be documented for safety assessment.
Clinical efficacy will be assessed by the appropriately trained evaluator using the WSRS and GAIS under blinded fashion, as well as by subjects using GAIS. Pre-treatment photographs of each subject taken at the pre-treatment (baseline) will be reviewed and will be used for comparison. The blinded evaluator will assess the photographs taken at each visit after the study device administration (photographic assessment). All subjects will perform the self-assessment by comparing their appearance in a mirror against a high-magnification photograph taken at baseline at each visit after the study device administration. The mirror symmetry will be reminded in all subjects. Under the explanation by the treating investigator or designee, subjects will assess the satisfaction of wrinkle improvement using the GAIS scoring.
Pain is going to be assessed using a patient self-assessment 10-cm visual analogue scale with anchors at 0 m (no pain) and 10 cm (extreme pain).
- Conditions
- Wrinkles Such as Nasolabial Folds
- Being tested
- PavéDerm J-Fill Soft Dermal Filler, Restylane® Lyft Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PavéDerm J-Fill Soft Dermal FillerDevice
Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL
Restylane® Lyft LidocaineDevice
Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (right) B (left) | Experimental | Subjects will receive PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine. One product will be randomized, per NLF. Receives: Device: PavéDerm J-Fill Soft Dermal Filler; Device: Restylane® Lyft Lidocaine |
| Treatment B (right) A (left) | Experimental | Subjects will receive Restylane® Lyft Lidocaine and PavéDerm J-Fill Soft Dermal Filler. One product will be randomized, per NLF. Receives: Device: PavéDerm J-Fill Soft Dermal Filler; Device: Restylane® Lyft Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.
Mean change of the Wrinkle Severity Rating Scale (WSRS) from baseline to Week 24 will be assessed by a blinded evaluator who will judge the severity score from taken photos based on the definition of WSRS Grades.
Measured: From baseline to Week 24.
Secondary outcomes (3)
The Mean change of the Wrinkle Severity Rating Scale assessed by the blinded evaluator.
Mean change of the Wrinkle Severity Rating Scale (WSRS) from baseline to Week 4 and Week 12 will be assessed by a blinded evaluator who will judge the severity score from taken photos based on the definition of WSRS Grades.
Measured: From baseline to Week 4 and 12.
Injection pain evaluated by the subjects after injection
Visual Analogue Scale for injection site pain assessment will be evaluated by the subject with anchors at 0 cm (no pain) and 10 cm (extreme pain) after the injection.
Measured: 0, and 15, 30, 45, and 60 minutes after the injection.
The Global Aesthetic Improvement Scale assessed by the blinded evaluator and subjects
- Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale (GAIS) from baseline to Week 4, 12, and 24 after injection will be evaluated by a blinded evaluator who will judge the severity score from taken photos based on the definition of GAIS Grades.
- Proportion of subjects with a ≥ 1 point on GAIS from baseline to Week 4, 12, and 24 after injection will be evaluated by the subjects based on a live assessment.
Measured: At Week 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start26 Dec 2019
- Primary completion15 Oct 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles Such as 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Chih-Chiang, Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040594
- Sponsor's protocol ID
- YSP-REN3010-001
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of PavéDerm J-Fill Soft Dermal Filler vs. Restylane® Lyft Lidocaine in the Treatment of Moderate to Severe Nasolabial Folds.
- ClinicalTrials.gov ID
- NCT05040594
- Acronym / sponsor ID
- YSP-REN3010-001
- Conditions
- Wrinkles Such as Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 10 Sep 2021 (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 purpose of this study is to evaluate the efficacy and safety of PavéDerm J-fill soft dermal filler vs. Restylane® Lyft lidocaine in the treatment of moderate to severe nasolabial folds.
Detailed description
This is a single-center, subject and evaluator blinded, intra-individual, split-face controlled clinical trial. After subjects voluntarily give written consent to the participation in the study, his/her eligibility for the study will be judged through demographic and past \& medication history investigation and laboratory test.
Subjects eligible in the screening will be enrolled. Each patient will receive PavéDerm J-Fill Soft Dermal Filler in one nasolabial fold and Restylane Lyft Lidocaine (20 mg/mL Hyaluronic acid with 3 mg/ml Lidocaine hydrochloride) in the other by randomization.
The faces of all subjects are going to be digitally photographed at rest upon every visit. The identical ambient conditions will be used for all photographs and assessments. To ensure blinding status, the subjects will be put on eye mask during injection. On injection day, subjects will receive injections, with at least 60 minute apart, to each nasolabial fold by the treating investigator. The amount of injection will be determined according to the width, length, and depth of the nasolabial folds to ensure optimal correction for each subject. The injected volume will not exceed 1.0 mL in ipsilateral nasolabial fold. The relevant information associated with the injection of the investigational medical device will be documented.
After each injection, the treating investigator will observe subjects through 30 minutes for assessment of adverse events. Subjects will be asked about adverse events at each follow-up visit, and any adverse events will be documented for safety assessment.
Clinical efficacy will be assessed by the appropriately trained evaluator using the WSRS and GAIS under blinded fashion, as well as by subjects using GAIS. Pre-treatment photographs of each subject taken at the pre-treatment (baseline) will be reviewed and will be used for comparison. The blinded evaluator will assess the photographs taken at each visit after the study device administration (photographic assessment). All subjects will perform the self-assessment by comparing their appearance in a mirror against a high-magnification photograph taken at baseline at each visit after the study device administration. The mirror symmetry will be reminded in all subjects. Under the explanation by the treating investigator or designee, subjects will assess the satisfaction of wrinkle improvement using the GAIS scoring.
Pain is going to be assessed using a patient self-assessment 10-cm visual analogue scale with anchors at 0 m (no pain) and 10 cm (extreme pain).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (right) B (left) | Experimental | Device: PavéDerm J-Fill Soft Dermal Filler, Device: Restylane® Lyft LidocaineSubjects will receive PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine. One product will be randomized, per NLF. |
| Treatment B (right) A (left) | Experimental | Device: PavéDerm J-Fill Soft Dermal Filler, Device: Restylane® Lyft LidocaineSubjects will receive Restylane® Lyft Lidocaine and PavéDerm J-Fill Soft Dermal Filler. One product will be randomized, per NLF. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 20 and 70.
- Subjects who want to improve bilateral nasolabial folds that are rated as 3 or 4 grades on the WSRS, and same WSRS scores on both sides (both sides are grade 3 or 4 on the WSRS).
- Subjects with visually symmetrical bilateral nasolabial folds.
- Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
- Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Key exclusion criteria (29 listed)
- Subjects who received an anticoagulant, thrombolytic, antiplatelet therapy or other substances are knownto increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba), or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 2 weeks prior to screening.
- -Except for low-dose aspirin (100 mg, up to 300 mg/day) or equivalent.
- Subjects who received/used a prohibited treatment/procedure as following:
- Subjects who received high dose vitamin E (e.g., 400 IU), corticosteroids, or interferon that may interfere with the treatment area or evaluation within 4 weeks prior to screening.
- The subject who received soft tissue augmentation as following at the investigational medical device injection site within a certain time frame prior to 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 |
|---|---|---|
| PavéDerm J-Fill Soft Dermal FillerSodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL | Device | Treatment A (right) B (left), Treatment B (right) A (left) |
| Restylane® Lyft LidocaineSodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL | Device | Treatment A (right) B (left), Treatment B (right) A (left) |
Primary outcome
The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator.
Time frame: From baseline to Week 24.
Mean change of the Wrinkle Severity Rating Scale (WSRS) from baseline to Week 24 will be assessed by a blinded evaluator who will judge the severity score from taken photos based on the definition of WSRS Grades.
3 secondary outcomes
The Mean change of the Wrinkle Severity Rating Scale assessed by the blinded evaluator.
Time frame: From baseline to Week 4 and 12.
Injection pain evaluated by the subjects after injection
Time frame: 0, and 15, 30, 45, and 60 minutes after the injection.
The Global Aesthetic Improvement Scale assessed by the blinded evaluator and subjects
Time frame: At Week 4, 12, and 24
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 10 Sep 2021.
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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.
Chen Chih-Chiang, Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PavéDerm J-Fill Soft Dermal Filler and Restylane® Lyft Lidocaine in people with Wrinkles Such as Nasolabial Folds, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
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 5 inclusion and 29 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 10 Sep 2021. 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 Taiwan. 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?
The Mean change of the Wrinkle Severity Rating Scale scored by the blinded evaluator. (time frame: From baseline to Week 24.). 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 10 Sep 2021.