AgingBeautyVolumeNCT04166292
The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
A study testing Stylage® XL Lidocaïne in people with Aging and Healthy, run by Laboratoires Vivacy at 1 site in France.
Trial summary
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Stylage® XL Lidocaïne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2019to 7 Aug 2021
- 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: male or female;
- Age: between 30 and 65 years;
- Subject having given freely and expressly his informed consent;
- Subject requiring injection on the cheekbones (upper part of the cheek);
- Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
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- Subject, psychologically able to understand the study related information and to give a written informed consent;
- 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 the beginning of the study and during all the study;
- Subject agreeing to keep their usual cleansing / care products during the whole study period;
- Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.
Who cannot join
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study;
- Subject with a scar, moles or anything on the face 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;
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- Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
- Intensive exposure to sunlight or Ultraviolet-rays (UV-rays) within the month before each visit;
- In terms of associated pathology
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency;
- 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 inclusion;
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
- Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device;
- Subject having history of allergy or anaphylactic shock including hypersensitivity to amide-type local anaesthetics or antiseptic solution;
- Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
- Subject with a tendency to develop keloids or hypertrophic scars;
- Subject with haemostatic disorder;
- Subject with porphyria;
- Relating to previous or ongoing treatment
- Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to inclusion;
- Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion;
- 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 filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …);
- Subject having received at any time a treatment with tensor threads on the face;
- Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to inclusion;
- Subject under medications that reduce or inhibit hepatic metabolism;
- Subject under medications which may cause lipo-atrophy;
- Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user;
- Subject undergoing a topical treatment on the test area or a systemic treatment;
- anti-histamines during the 2 weeks prior to study start;
- immunosuppressors and/or corticoids during the 4 weeks prior to study start;
- retinoids during the 6 months prior to study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Monocentric, Uncontrolled Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
Read the detailed description
This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring.
The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).
The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale).
Facial volume variation (evaluated by an independent evaluator) \& treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin \& chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.
- Being tested
- Stylage® XL Lidocaïne
- Keywords
- augmentation, restoration, dermal filler, face, cheekbone, chin, mandibular angle, hyaluronic acid
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stylage® XL LidocaïneDevice
On V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face.
On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml.
| Study group | Role | What they receive |
|---|---|---|
| Treated face | Experimental | The device will be injected on V1 (D0) in the cheekbones (upper part of the cheek) for all subjects and in the chin for 20 subjects minimum and if needed (optional areas) in the temple, and facial oval (mandibular angle and border). A touch-up is possible in one or several of these areas on V2 (M1). Optional treated areas will be at the discretion of subjects and injectors. Receives: Device: Stylage® XL Lidocaïne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of facial volume
Facial volume variation from baseline to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale). Graded scale from 1-5; 5 being the most severe
Measured: 6 months
Secondary outcomes (8)
Variation of facial volume
Facial volume variation from baseline to 1, 3, 12 and 18 months after treatment initiation measured by an independent evaluator on photographs using FVLS scale.Graded scale from 1-5; 5 being the most severe
Measured: Month 1, Month 3, Month 12, Month 18
Treatment responders rate
Rate of treatment responders at 1, 3, 6, 12 and 18 months measured by an independent evaluator on photographs using FVLS scale. Graded scale from 1-5; 5 being the most severe
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Global aesthetic improvement
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the global aesthetic improvement measured by an independent evaluator on photographs using the GAIS (Global Aesthetic Improvement Scale). 5 possibles grades : 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Patient self-assessed aesthetic improvement
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the global aesthetic improvement measured by subjects using the GAIS. 5 possibles grades : 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of volume on the cheekbones, and on the chin for applicable subjects
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the volume on the cheekbones (upper part of the cheek) and on the chin, for applicable subjects, using the 3D QuantifiCare system.
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of the chin angle for applicable subjects
Variation from baseline to 1, 3, 6, 12 and 18 months after treatment initiation of the chin angle for applicable subjects using the 3D QuantifiCare system.
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Evolution of subject's satisfaction
Evolution of subject's satisfaction from baseline to 1, 3, 6, 12 and 18 months after treatment initiation using the FACE-Q satisfaction with cheekbones and the FACE-Q satisfaction with chin questionnaires.
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Report of adverse events
Evaluation of product tolerance by collection of adverse events.
Measured: Month 1, Month 3, Month 6, Month 12, Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start21 Nov 2019
- Primary completion15 Jul 2020
- Study completion7 Aug 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain-Ali MOJALLAL, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166292
- Sponsor's protocol ID
- 2019-A01404-53
- Acronym
- BeautyVolume
- Status last verified
- May 2022
- First submitted
- 14 Nov 2019
- Last updated
- 18 May 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 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Monocentric, Uncontrolled Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
- ClinicalTrials.gov ID
- NCT04166292
- Acronym / sponsor ID
- BeautyVolume / 2019-A01404-53
- Keywords
- augmentation, restoration, dermal filler, face, cheekbone, chin, mandibular angle, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 7 Aug 2021 (actual)
- First posted
- 18 Nov 2019 (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® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
Detailed description
This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring.
The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).
The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale).
Facial volume variation (evaluated by an independent evaluator) \& treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin \& chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated face | Experimental | Device: Stylage® XL LidocaïneThe device will be injected on V1 (D0) in the cheekbones (upper part of the cheek) for all subjects and in the chin for 20 subjects minimum and if needed (optional areas) in the temple, and facial oval (mandibular angle and border). A touch-up is possible in one or several of these areas on V2 (M1). Optional treated areas will be at the discretion of subjects and injectors. |
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: male or female;
- Age: between 30 and 65 years;
- Subject having given freely and expressly his informed consent;
- Subject requiring injection on the cheekbones (upper part of the cheek);
Key exclusion criteria (32 listed)
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study;
- Subject with a scar, moles or anything on the face 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;
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® XL LidocaïneOn V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face. On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml. | Device | Treated face |
Primary outcome
Variation of facial volume
Time frame: 6 months
Facial volume variation from baseline to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale). Graded scale from 1-5; 5 being the most severe
8 secondary outcomes
Variation of facial volume
Time frame: Month 1, Month 3, Month 12, Month 18
Treatment responders rate
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Global aesthetic improvement
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Patient self-assessed aesthetic improvement
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of volume on the cheekbones, and on the chin for applicable subjects
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Variation of the chin angle for applicable subjects
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Evolution of subject's satisfaction
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
Report of adverse events
Time frame: Month 1, Month 3, Month 6, Month 12, Month 18
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 18 May 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.
Alain-Ali MOJALLAL, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stylage® XL Lidocaïne in people with Aging and Healthy, run by Laboratoires Vivacy at 1 site in France.
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 32 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 18 May 2022. 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 France. 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?
Variation of facial volume (time frame: 6 months). 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 18 May 2022.