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AgingNCT04861766

Safety and Effectiveness of STYLAGE® L for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults

A study testing STYLAGE® L and Active Comparator in people with Aging and Skin Wrinkling, run by Laboratoires Vivacy at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Skin Wrinkling
What is being tested?
STYLAGE® L and Active Comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
8 sitesChina
Study dates
6 May 2021to 31 Mar 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women aged ≥ 18 years.
  • Chinese ethnicity.
  • Subjects who wanting to correct his/her nasolabial folds
  • Subjects with moderate to severe nasolabial folds (attaining grade 3 on both side or 4 on both side) in the WSRS of nasolabial fold, per assessment of the Blinded Evaluator.
  • Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
  • Subjects with realistic expectations who can understand and comply with the instructions and all visit schedule.
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  • Women of childbearing potential (WOCBP) who agree contraception during the study period.
  • Subjects who voluntarily decided the participation of the study and signed the informed consent.
  • Being able to stand mild pain.

Who cannot join

  • Subjects who are contraindicated to augmentation with HA fillers
  • Subjects who had a history of keloid formation or hypertrophic scar
  • Subjects presenting a scar or skin disorder (i.e. active dermal disease [facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc], inflammation or an unhealed wound) below the level of the lower orbital rim that may confound the study evaluation
  • Has ever received semi-permanent fillers or permanent facial implants (eg, calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere below the inferior orbital rim, or is planning to be implanted with any of these products at any time during the study
  • Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) below the inferior orbital rim within 12 months before enrollment or is planning to undergo such treatment during the study
  • Has undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures (eg, facial liposuction, aesthetic surgery, face-lift, photomodulation, intense pulsed light, radio frequency, dermabrasion, laser or chemical peel, or other ablative procedures) below the inferior orbital rim within 6 months before enrollment or is planning to undergo any such treatment during the study
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  • Subjects who has any history of severe multiple allergies or an allergy resulting in anaphylaxis, or an allergy to hyaluronic acid and/or one of the ingredients of the study products
  • Subject is pregnant or planning to be pregnant during the study period or lactating. Women of childbearing potential who have a positive pregnancy test result during screening. Women of childbearing potential who are unwilling to use effective birth control measures during the full course of the study
  • Subject suffering from a serious or progressive disease, which, in the Investigator's judgment, put the subject at undue risk for participation in this clinical trial (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure [classified as NYHA III-IV], etc), , etc.)
  • Subject having a history of cancer within 5 years
  • Subjects who received oral surgery (eg. tooth extraction, orthodontia or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
  • Subject has history or active autoimmune disease (e.g. inflammatory bowel disease), active or history of connective tissue disease (rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
  • Subjects with current or a history of hemorrhagic diseases
  • Subject who received chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic corticosteroids within 3 months (inhaled corticoids are allowed).
  • Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product per Investigator's judgement
  • Subjects who participated in other clinical trial within 30 days or who is in an exclusion period of one.
  • Subjects with uncontrolled hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg at resting status), and/or significant liver (serum ALT or AST ≥2X the upper limit of the reference range), kidney (BUN, Urea or Cr≥1.5X the upper limit of the reference range), and/or blood coagulation (PT, or APTT, or INR> 20% of the reference range) disorders per judgement of the Investigator.
  • Current or a history of alcoholism, drug abuse, or drug dependence.
  • Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
  • Subject with a past history of streptococcal disease (manifested by recurrent sore throat or acute rheumatic fever) or with an active infection to streptococcus
  • Has facial hair (e.g., beards, sideburns, etc.), piercing or tattoo in the area to be treated that would interfere with investigation assessments and create inconsistency in required investigation photography during the study period
  • Personnel of the study department, close relatives of the study department personnel (i.e. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor or CRO company.
  • Other conditions the Investigator considers inappropriate for enrollment

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Hospital

    Beijing, Dong Cheng District, 100730

  • Air Force Medical Center, PLA

    Beijing, Haidian District, 100142

  • Peking University Third Hospital

    Beijing, Haidian District, 100191

  • Peking University First Hospital

    Beijing, Xicheng District, 100034

  • West China Hospital of Stomatology Sichuan University

    Chengdu, Sichuan, 610041

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • SUN YAT-SEN Memorial Hospital, SUN YAT-SEN University

    Guangzhou, Guangdong, 510289

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317

Other trials in China

About this study

Official title: A Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study of the Safety and Effectiveness of STYLAGE® L Versus Restylane® for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults

This is a safety and efficacy study of STYLAGE® Lin Chinese adults with Nasolabial Folds.

Read the detailed description

This is a prospective, multi-center, parallel-group, subject and evaluator-blinded, randomized controlled trial to demonstrate the non-inferiority of the study device, STYLAGE® L, when compared to an active comparator for the correction of moderate and severe NLFs.

Subjects will randomly receive STYLAGE® L or the active comparator (ratio 1:1) injection in the NLFs at first visit on Day 0.

Proportion of subjects having a NLFs severity improvement (blinded evaluation), 6 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 3, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator and subject, subjects' satisfaction, and safety parameters will also be assessed during the study period.

Being tested
STYLAGE® L, Active Comparator
Keywords
hyaluronic acid, Nasolabial Folds, Dermal filler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STYLAGE® LDevice

    Injection in both NLFs

  • Active ComparatorDevice

    Injection in both NLFs

Study groups in NCT04861766
Study groupRoleWhat they receive
Treatment group Stylage L ®ExperimentalEach subject will receive STYLAGE® L in both NLFs. STYLAGE® L will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1.
Receives: Device: STYLAGE® L
Control group Active ComparatorActive comparatorEach subject will receive the Active Comparator in both NLFs. Active Comparator will be injected in the NLFs by the Treating Investigator with optional touch-up injections on Month 1.
Receives: Device: Active Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WSRS improvement

    Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator at 6 months after last treatment for both groups.

    Measured: Month 6

Secondary outcomes (5)

  1. WSRS improvement

    Percentage of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the Blinded Evaluator

    Measured: 1, 3, 9, and 12 months

  2. GAIS assessment

    Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Global Aesthetic Improvement Scale (GAIS), as assessed by the subject and the Treating Investigator

    Measured: 1, 3, 9, and 12 months

  3. Subject satisfaction assessment

    Percentage of satisfied subjects on each question of the subject satisfaction assessment

    Measured: 1, 3, 6, 9, and 12 month

  4. Device performance

    Results of device performance evaluation after the initial and touch-up injection, respectively, by the Treating Investigator for both groups.

    Measured: initial and touch up

  5. Report of Adverse Event

    Product safety will be assessed by collection of local tolerability after each injection session, and Adverse Events (AEs) throughout the study.

    Measured: Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start6 May 2021
  3. Primary completion16 Aug 2022
  4. Study completion31 Mar 2023

Resources

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 Controlled, Prospective, Randomized, Multi-Center, Subject and Evaluator-Blinded Study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04861766
Sponsor's protocol ID
VIV-STYL-L-01
Status last verified
Apr 2023
First submitted
26 Apr 2021
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing STYLAGE® L and Active Comparator in people with Aging and Skin Wrinkling, run by Laboratoires Vivacy at 8 sites in China.

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 9 inclusion and 23 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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?

WSRS improvement (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04861766.

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 19 Apr 2023.

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