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

NCT05009381 | Completed

• 1 other identifier: VIV-STYL-XXL-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 5

Brief 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 be verified together with assessments of the safety profiles.

Conditions

Esthetic

Keywords

Chin; Hyaluronic Acid; volume; HA fillers

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (29)

• Chin volume change in ml

  3 months

• Glabella-subnasale-pogonion angle change in degrees

  1,3 and 6 months

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

  1,3 and 6 months

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

  1,3 and 6 months

• Subject satisfaction assessment

  1,3 , 6 , 9 , 12 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Treatment group will receive STYLAGE® XXL at enrollment with an optional touch up injection 30 days later

Device: Stylage XXL at enrollment

control group

EXPERIMENTAL

Control 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.

Device: Stylage XXL at Month 6

Interventions

Stylage XXL at enrollment DEVICE

Injection in the chin at enrollment

Treatment group

Stylage XXL at Month 6 DEVICE

Injection in the chin 6 months after randomization

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (5)

Beijing Hospital

Beijing, Dong Cheng District, 100730, China

Location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

Peking University Third Hospital

Beijing, Haidian District, 100191, China

Location

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, 610041, China

Location

Peking University First Hospital

Beijing, Xicheng District, 100034, China

Location

Study Officials

• Yan Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary hypothesis of this trial will be based on the chin volume change assessed by a central reader blinded to subject treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A no-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 17, 2021
• Study Start: September 10, 2021
• Primary Completion: October 26, 2022
• Study Completion: August 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (5)