AgingNICENCT04844216
Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds
A study testing STYLAGE® L Lidocaine in people with Aging, run by Laboratoires Vivacy at 2 sites in 2 countries.
Trial summary
STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- STYLAGE® L Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Apr 2021to 6 Jul 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: female or male.
- Age: between 30 and 65 years.
- Subject having given freely and expressly his/her informed consent and data privacy consent.
- Subject with approximate symmetry, moderate to severe Nasolabial Folds (NLFs) attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for NLF, as assessed in live.
- Subject with marionette's lines that do not require to be treated according to investigator.
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- Subject willing to have photographs of the face taken.
- Subject, psychologically able to understand the study related information and to give a written informed consent.
- Subject agreeing not to receive another aesthetic procedure on the face (e.g., laser, dermabrasion, surgery, deep chemical peeling, surface peel, tensor threads, injection with a filling product) during the whole study.
- Subject affiliated to a health social security system.
- Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit and during the whole study.
Who cannot join
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject participating to another research on human beings or who is in an exclusion period of one.
- For France only: subject having received 4500 euros indemnities for participation in researches involving human beings in France in the 12 previous months, including participation in the present study.
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- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- Subject suffering from untreated epilepsy.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats and in case of acute rheumatic fever with heart complications.
- Subjects suffering from porphyria.
- Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is not eligible even if asymptomatic at time of screening visit.
- Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to gram positive bacterial proteins, to lidocaine, to one of the components of the tested devices or antiseptic solution or amide-type local anaesthetics.
- Subject having history of severe and/or evolutive / unstable / recent allergy.
- Subject predisposed to develop keloids or hypertrophic scarring.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subjects with known cardiac conduction disorders.
- Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure below the inferior orbital rim within the past 12 months prior to screening visit.
- Subject having received treatment with a surface peel below the inferior orbital rim within the past 6 months prior to screening visit.
- Subject having received injection with a resorbable filling product (eg, hyaluronic acid, collagen) below the inferior orbital rim within the past 12 months prior to screening visit.
- Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable permanent filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …).
- Subject having received at any time a treatment with tensor threads below the inferior orbital rim.
- Subject who received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to screening visit or who plans to undergo any of these procedures during the study.
- Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
- Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofène, naproxène, …), antiplatelet agents, anticoagulants, vitamin C or other substances known to prolong bleeding time (warfarin, , herbal supplements with garlic or ginkgo biloba, …) within 1 week prior to injection visit (V1) and agreeing not to take such treatments within 1 week prior to touch-up visit, or being a chronic user.
- Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc).
- Total injection volume of cross-linked hyaluronic acid >14 mL within 1 year prior to screening visit.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- Anti-histamines during the 2 weeks prior to injection visit (V1) and agreeing not to take such treatment within 2 weeks prior to touch-up visit;
- Immunosuppressors and/or corticoids during the 4 weeks prior to screening visit;
- Retinoids during the 6 months prior to screening visit.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.
Read the detailed description
This is a prospective, multicenter, randomized, controlled versus active treatment, within-subjects study with blinded subjects and evaluators assessing the efficay and safety of STYLAGE® L Lidocaine in the treatment of nasolabial folds. Fifty healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive dermal injections consisting in a maximum of 2 mL of STYLAGE® L Lidocaine on one nasolabial fold and a maximum of 2 mL of an active comparator on the other nasolabial fold. A touch-up consisting in the dermal injection of maximum 1 mL of product per nasolabial fold is possible if required one month after. Subjects will be followed up at 1, 3, 6, 9 and 12 months timepoints. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent blinded evaluators using the validated 5-point Wrinkles Severity Rating Scale (WSRS). Global aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Variation in nasolabial fold depth will be assessed using Dermatop®. Subject satisfaction, pain at injection site and safety will also be assessed.
- Conditions
- Aging
- Being tested
- STYLAGE® L Lidocaine, Active control
- Keywords
- Aging, Hyaluronic acid, Nasolabial fold, Injection, Healthy subjects, Independent evaluators, Prospective, Randomized study, Within-subject, Controlled, Multicenter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLAGE® L LidocaineDevice
Also called Injection of hyaluronic acid gel
An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).
Active controlDevice
Also called Injection of hyaluronic acid gel
An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).
| Study group | Role | What they receive |
|---|---|---|
| Nasolabial fold treated with experimental device | Experimental | STYLAGE® L Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection.
Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up). Receives: Device: STYLAGE® L Lidocaine |
| Nasolabial fold treated with comparator | Active comparator | The active comparator is a hyalorunic acid injectable gel whose intended purpose is the filling of mid and/or deep depressions of the skin via mid and/or deep dermal injection.
Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up). Receives: Device: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in nasolabial fold severity assessed in live
Mean change in nasolabial fold severity from baseline to 6 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS). The Wrinkles Severity Rating Scale is a 5-grade scale (from grade 1 to grade 5) with minimum grade representing a better outcome. Grade 1 corresponds to "Absent", grade 2 to "Mild", grade 3 to "Moderate", grade 4 to "Severe" and grade 5 to "Extreme".
Measured: Month 6
Secondary outcomes (9)
Mean change in nasolabial fold severity assessed in live
Mean WSRS change from baseline to 1, 3, 9 and 12 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS).
Measured: Month 1, Month 3, Month 9, Month 12
Mean change in nasolabial fold severity assessed on photographs
Mean WSRS change from baseline to 1, 3, 6, 9 and 12 months after treatment initiation as assessed by a blinded independent evaluator on photographs, using the validated 5-point Wrinkles Severity Rating Scale (WSRS).
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of WSRS responder rate
WSRS responder rates 1, 3, 6, 9 and 12 months after treatment initiation as assessed by a blinded live independent evaluator and a blinded independent evaluator on photographs. A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS.
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of global aesthetic improvement
Mean global aesthetic improvement from 1, 3, 6, 9 and 12 months after treatment initiation by subjects and a blinded live independent evaluator using the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a 5-score scale (from score 1 to score 5) with minimum scores representing a better outcome. Score 1 corresponds to "Very improved", score 2 to "Much improved", score 3 to "Improved", score 4 to "No change" and score 5 to "Worse".
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of GAIS responder rate
GAIS responder rates 1, 3, 6, 9 and 12 months after treatment initiation as assessed by subjects and a blinded live independent evaluator. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Mean change in nasolabial fold depth
Mean change in nasolabial fold depth from baseline to 1, 3, 6, 9 and 12 months after treatment initiation using Dermatop®.
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of subject's satisfaction
Evaluation of subject's satisfaction 1, 3, 6, 9 and 12 months after treatment initiation using a questionnaire.
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of pain during injection
Evaluation of pain during injection by subjects on an 11-point numeric rating scale (0 to 10).
Measured: Day 0, Month 1
Report of adverse events
Product tolerance will be assessed by collection of Injection Site Reactions (ISRs) after each injection session, and Adverse Events throughout the study.
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start16 Apr 2021
- Primary completion13 Jan 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Single group
- Model description
- Within-subject study with treatment of one nasolabial fold with the investigational medical device and treatment of the other nasolabial fold with a comparator (another medical device).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophie CONVERSET-VIETHEL, MD, Principal investigator, Cabinet de chirugie de la face et du cou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844216
- Sponsor's protocol ID
- 2020-A03409-30
- Acronym
- NICE
- Status last verified
- Aug 2022
- First submitted
- 8 Apr 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04844216
- Acronym / sponsor ID
- NICE / 2020-A03409-30
- Conditions
- Aging
- Keywords
- Aging, Hyaluronic acid, Nasolabial fold, Injection, Healthy subjects, Independent evaluators, Prospective, Randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 14 Apr 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.
STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.
Detailed description
This is a prospective, multicenter, randomized, controlled versus active treatment, within-subjects study with blinded subjects and evaluators assessing the efficay and safety of STYLAGE® L Lidocaine in the treatment of nasolabial folds. Fifty healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive dermal injections consisting in a maximum of 2 mL of STYLAGE® L Lidocaine on one nasolabial fold and a maximum of 2 mL of an active comparator on the other nasolabial fold. A touch-up consisting in the dermal injection of maximum 1 mL of product per nasolabial fold is possible if required one month after. Subjects will be followed up at 1, 3, 6, 9 and 12 months timepoints. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent blinded evaluators using the validated 5-point Wrinkles Severity Rating Scale (WSRS). Global aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Variation in nasolabial fold depth will be assessed using Dermatop®. Subject satisfaction, pain at injection site and safety will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject study with treatment of one nasolabial fold with the investigational medical device and treatment of the other nasolabial fold with a comparator (another medical device).
| Arm | Type | Receives |
|---|---|---|
| Nasolabial fold treated with experimental device | Experimental | Device: STYLAGE® L LidocaineSTYLAGE® L Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection. Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up). |
| Nasolabial fold treated with comparator | Active comparator | Device: Active controlThe active comparator is a hyalorunic acid injectable gel whose intended purpose is the filling of mid and/or deep depressions of the skin via mid and/or deep dermal injection. Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subject.
- Sex: female or male.
- Age: between 30 and 65 years.
- Subject having given freely and expressly his/her informed consent and data privacy consent.
- Subject with approximate symmetry, moderate to severe Nasolabial Folds (NLFs) attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for NLF, as assessed in live.
Key exclusion criteria (31 listed)
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject participating to another research on human beings or who is in an exclusion period of one.
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 |
|---|---|---|
| STYLAGE® L LidocaineAlso: Injection of hyaluronic acid gelAn injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1). | Device | Nasolabial fold treated with experimental device |
| Active controlAlso: Injection of hyaluronic acid gelAn injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1). | Device | Nasolabial fold treated with comparator |
Primary outcome
Mean change in nasolabial fold severity assessed in live
Time frame: Month 6
Mean change in nasolabial fold severity from baseline to 6 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS). The Wrinkles Severity Rating Scale is a 5-grade scale (from grade 1 to grade 5) with minimum grade representing a better outcome. Grade 1 corresponds to "Absent", grade 2 to "Mild", grade 3 to "Moderate", grade 4 to "Severe" and grade 5 to "Extreme".
9 secondary outcomes
Mean change in nasolabial fold severity assessed in live
Time frame: Month 1, Month 3, Month 9, Month 12
Mean change in nasolabial fold severity assessed on photographs
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of WSRS responder rate
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of global aesthetic improvement
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of GAIS responder rate
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Mean change in nasolabial fold depth
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of subject's satisfaction
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Evaluation of pain during injection
Time frame: Day 0, Month 1
Report of adverse events
Time frame: Up to Month 12
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 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Sophie CONVERSET-VIETHEL, MD principal investigator
Cabinet de chirugie de la face et du cou
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STYLAGE® L Lidocaine in people with Aging, run by Laboratoires Vivacy at 2 sites in 2 countries.
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 11 inclusion and 31 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Poland. 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?
Mean change in nasolabial fold severity assessed in live (time frame: Month 6). 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 4 Aug 2022.