A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

Study Overview
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Brief Summary
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This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

Official Title
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A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw

Conditions
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Chin Retrusion

Intervention / Treatment
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* Device: Hyaluronic Acid Injectable Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Has chin retrusion. Exclusion Criteria: Has ever received or is planning to receive permanent facial implants during the study. Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw. Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study. Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study. Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study. Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study. Has experienced trauma to the chin and jaw area within 6 months. Has been previously diagnosed with streptococcal disease. Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein. Has porphyria or untreated epilepsy. Has active autoimmune disease. Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion. Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism. Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction. Is on an ongoing regimen of anti-coagulation therapy. Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days. Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group_VYC-25L<br>VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable | Device: Hyaluronic Acid Injectable Gel<br>* Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).<br>|
| Other: Control Group_No treatment then VYC-25L<br>No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable. | Device: Hyaluronic Acid Injectable Gel<br>* Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle |  | Baseline, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS) |  | Month 3 | 
| Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS |  | Month 3 |