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EstheticNCT05009381

Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults

A study testing Stylage XXL at enrollment and Stylage XXL at Month 6 in people with Esthetic, run by Laboratoires Vivacy at 5 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

The aim of this trial is to demonstrate the efficacy and safety of STYLAGE® XXL in augmenting the chin volume among Chinese adults. Subjects will be randomized either to the treatment group or the control group in a 4:1 ratio The superiority of STYLAGE® XXL against no-treatment control in chin volume augmentation will… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Esthetic
What is being tested?
Stylage XXL at enrollment and Stylage XXL at Month 6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
5 sitesChina
Study dates
10 Sep 2021to 31 Aug 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

  • Chinese ethnicity
  • Subjects seeking for chin volume augmentation
  • Per Investigator's assessment, subjects who require 1 to 4 mL total volume of STYLAGE® XXL for chin augmentation to achieve a meaningful improvement and/or change in their aesthetic appearance.
  • With realistic expectations who can understand and comply with the instructions and all visit schedule.
  • Willing to abstain from other facial cosmetic procedures (e.g., further augmentation therapy, botulinum toxin injections, laser or chemical skin resurfacing, or face lift procedures) below the level of the horizontal line from subnasale for the duration of the study.
  • 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 injection with HA fillers.
  • Subjects who had a history of keloid formation or hypertrophic scar.
  • Subjects presenting a scar or skin disorder (e.g., active dermal disease [facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc], inflammation or an unhealed wound) below the level of the horizontal line from subnasale that may confound the study evaluation.
  • Has ever received permanent (non-biodegradable) or semi-permanent fillers or permanent facial implants (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene), or fat injections below the level of the horizontal line from subnasale, 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) for facial tissue augmentation therapy in the chin and/or lips within 12 months before enrollment or is planning to undergo such treatment during the study
  • Has undergone botulinum toxin injections, mesotherapy, or cosmetic facial procedures (e.g., facial liposuction, aesthetic surgery, face-lift, photomodulation, intense pulsed light, radio frequency, dermabrasion, laser or chemical peel, or other ablative procedures) below the level of the horizontal line from subnasale within 6 months 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 a hypersensivity 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 or at baseline. Women of childbearing potential who are unwilling to use effective birth control measures during the full course of the study.
  • Subject currently 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 (e.g., cancer or pre-cancer, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (e.g., stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure [classified as NYHA III-IV], etc.) etc.).
  • Subjects having history of cancer within 5 years
  • Subjects who received oral surgery (e.g., tooth extraction, orthodontia or implantation) or sinus surgery 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.
  • Subjects who received chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g., monoclonal antibodies), systemic corticosteroids within 3 months before treatment (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 (e.g., in the screening period of another trial).
  • Subjects with 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 disorders (PT, APTT or INR >20% of the reference range).
  • 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 site personnel (e.g., 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

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Hospital

    Beijing, Dong Cheng District, 100730

  • 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

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317

Other trials in China

About this study

Official title: A No-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study to Evaluate the Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults

The aim of this trial is to demonstrate the efficacy and safety of STYLAGE® XXL in augmenting the chin volume among Chinese adults.

Subjects will be randomized either to the treatment group or the control group in a 4:1 ratio

The superiority of STYLAGE® XXL against no-treatment control in chin volume augmentation will be verified together with assessments of the safety profiles.

Read the detailed description

This study is a no-treatment controlled, prospective, randomized, multi-center, evaluator-blinded study, in Chinese subjects seeking for chin volume augmentation.

150 subjects will be randomized either to the treatment group or the control group in a 4:1 ratio (120 subjects in the treatment group and 30 subjects in the control group).

Subjets assigned to the treatment group will receive STYLAGE® XXL at enrollment.

Subjects assigned to the control group will not receive treatment at enrollment; however, at 6 month visit, subjects who are still eligible for chin augmentation with STYLAGE® XXL will be treated

STYLAGE® XXL superiority will be demonstrated against no-treatment control in augmenting the chin volume, as measured by blinded evaluator at 6-month

Conditions
Esthetic
Being tested
Stylage XXL at enrollment, Stylage XXL at Month 6
Keywords
Chin, Hyaluronic Acid, volume, HA fillers

What participants receive

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

  • Stylage XXL at enrollmentDevice

    Injection in the chin at enrollment

  • Stylage XXL at Month 6Device

    Injection in the chin 6 months after randomization

Study groups in NCT05009381
Study groupRoleWhat they receive
Treatment groupExperimentalTreatment group will receive STYLAGE® XXL at enrollment with an optional touch up injection 30 days later
Receives: Device: Stylage XXL at enrollment
control groupExperimentalControl group will not be treated at enrollment visit. Subjects will receive STYLAGE® XXL at visit 6 months after randomization, if they are still eligible for chin augmentation with an optional touch up injection 30 days later.
Receives: Device: Stylage XXL at Month 6

What is being measured

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

  1. Chin volume change in ml

    Chin volume change in ml, from baseline to 6 months (after last treatment in the treatment group, and after randomization in the control group) between the treatment and control groups as measured by the blinded evaluator using the 3D system.

    Measured: 6 months

Secondary outcomes (29)

  1. Chin volume change in ml

    Chin volume change in ml, from baseline to 1- and 3- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups as measured by the blinded evaluator using the 3D system

    Measured: 3 months

  2. Glabella-subnasale-pogonion angle change in degrees

    Glabella-subnasale-pogonion angle change in degrees, from baseline to 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups as measured by the blinded evaluator using the 3D system

    Measured: 1,3 and 6 months

  3. Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the Treating investigator

    Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Treating Investigator assessed Global Aesthetic Improvement Scale (GAIS), at 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups.

    Measured: 1,3 and 6 months

  4. Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the subject

    Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Subject assessed Global Aesthetic Improvement Scale (GAIS), at 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively , between the treatment and control groups.

    Measured: 1,3 and 6 months

  5. Subject satisfaction assessment

    Percentage of satisfied subjects on each question of the subject satisfaction questionnaire The response scale for each question consists of five categories (strongly agree, agree, not sure, disagree, strongly disagree). A subject will be considered as "satisfied" if the answer is "strongly agree" or "agree" in that question.

    Measured: 1,3 , 6 , 9 , 12 months

  6. Results of device performance evaluation respectively.

    The Treating Investigator will be asked to rate the: (1) ease of injection, (2) extrusion force, and (3) moldability/malleability on an 11-point numeric scale ranged from 0 (Easy) to 10 (Hard)

    Measured: Day 1 and 1 month

  7. Safety : report of AE / SAEs

    Adverse Events (AEs) report throughout the study

    Measured: 1,3,6 months

  8. Safety : Vital signs Body temperature

    Body temperature will be measured and recorded in degrees Celsius

    Measured: Screening, Day 1, 1,3,6,9,12 months

  9. Safety : Vital signs Heart rate

    Heart rate : Subjects should be seated at rest to measure heart rate . Heart rate measurements should be made by counting heartbeats for a period of 30 seconds and multiplying these values by 2 to obtain the rates per minute

    Measured: Screening, Day 1, 1,3,6,9,12 months

  10. Safety : Vital signs respiration rate

    Respiration rate :Subjects should be seated at rest to measure respiratory rate.. Respiration rate will be recorded by counting the number of breath cycles in 1 minute.

    Measured: Screening, Day 1, 1,3,6,9,12 months

  11. Safety : Vital signs Blood pressure

    Blood pressure (systolic and diastolic) : Blood pressure will be measured in sitting position at rest using a standardized sphygmomanometer equipped in the site and standardized cuff adapted to the size of the subject's arm. The blood pressure is recorded in millimeters of mercury (mmHg)

    Measured: Screening, Day 1, 1,3,6,9,12 months

  12. Safety : Physical evaluation

    The physical evaluation is a test to determine the overall health of the subject. The investigator will inspect the following parts of body : Skin and mucous, lymph nodes, head (eyes, nose, ears, mouth), neck (thyroid, vessels, trachea) , chest (heart, lungs), abdomen (liver, spleen, kidney) , muscle-skeleton and neurologic systems by checking consistency,location, size, tenderness, and texure of the individual organs.

    Measured: screening and 12 months

  13. Safety : Physical evaluation BMI

    Height is measured in meter, weight is measured in kg, BMI is calculated in kg/m^2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

    Measured: screening and 12 months

  14. Safety : Physical evaluation Visual inspection of the skin

    Visual inspection of the skin in the injection area (e.g., sclerosis, pruritus, pain, reddish, edema, bruises, ecchymosis, infection, inflammation, allergy, and formation of scar and/or granuloma, etc.).

    Measured: 1 month

  15. Safety : Clinical Laboratory evaluation PT and APTT

    Blood coagulation: PT(prothrombin time), and APTT (activated partial thromboplastin time) are measured in seconds

    Urinalysis: pH, leucocytes, nitrites, protein, blood, glucose Pregnancy testing

    Measured: Screening, 1 month , 12 months

  16. Safety : Clinical Laboratory evaluation INR

    INR (international normalized ratio) is calculated as a ratio of the patient's PT in seconds to a control PT standardized in seconds

    Measured: Screening, 1 month , 12 months

  17. Safety : Clinical Laboratory evaluation FIB

    FIB (Fibrinogene) is measured in g/L

    Measured: Screening, 1 month , 12 months

  18. Safety : Clinical Laboratory evaluation Glucose and electrolytes

    Blood Glucose and serum electrolytes (Na+、K+、Cl-、Ca2+, Mg2+) are measured in mmol/L

    Measured: Screening, 1 month , 12 months

  19. Safety : Clinical Laboratory evaluation Hepatic function

    ALT/AST aminotransferase enzymes are measured in units/L of serum

    Measured: Screening, 1 month , 12 months

  20. Safety : Clinical Laboratory evaluation Renal function

    BUN (blood urea nitrogen) and plasma creatinine in mg/dL

    Measured: Screening, 1 month , 12 months

  21. Safety : Clinical Laboratory evaluation Hematology cells

    RBC count, WBC count with differential are expressed in cells/ mcL (including absolute WBC count, absolute count and percentage of the 5 WBC differentials including neutrophil, eosinophil, basophil, lymphocyte, and monocyte)

    Measured: Screening, 1 month , 12 months

  22. Safety : Clinical Laboratory evaluation hematology Hb

    Hb (hemoglobin) in g/dL

    Measured: Screening, 1 month , 12 months

  23. Safety : Clinical Laboratory evaluation hematology HCT

    HCT (hematocrit) in %

    Measured: Screening, 1 month , 12 months

  24. Safety : Clinical Laboratory evaluation Hematology PLT

    PLT count (platelets/mcL)

    Measured: Screening, 1 month , 12 months

  25. Safety : Clinical Laboratory evaluation Urinalysis pH

    pH

    Measured: Screening, 1 month , 12 months

  26. Safety : Clinical Laboratory evaluation Urinalysis leucocytes

    leucocytes in wbc/hpf.

    Measured: Screening, 1 month , 12 months

  27. Safety : Clinical Laboratory evaluation Chemical Urinalysis

    nitrites, protein, blood, glucose : dispstick urinalysis

    Measured: Screening, 1 month , 12 months

  28. Safety : Clinical Laboratory evaluation Pregnancy testing

    β-hCG in urine or serum (mIU/mL)

    Measured: Screening, 1 month , 12 months

  29. Safety : ECG

    Standard ECGs (12-Lead ECG or 15 Lead ECG) will be recorded in a supine position at resting status

    Measured: Screening, 1 month

Timeline

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

  1. First posted17 Aug 2021
  2. Study start10 Sep 2021
  3. Primary completion26 Oct 2022
  4. Study completion31 Aug 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 no-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009381
Sponsor's protocol ID
VIV-STYL-XXL-01
Status last verified
Sep 2023
First submitted
16 Jul 2021
Last updated
21 Sep 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 XXL at enrollment and Stylage XXL at Month 6 in people with Esthetic, run by Laboratoires Vivacy at 5 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 8 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Chin volume change in ml (time frame: 6 months). 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 NCT05009381.

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 21 Sep 2023.

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