Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions

Study Overview
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Brief Summary
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This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA) injectable gel for filling fine lines, as measured by skin texture improvement, and for improvement of skin quality.

Official Title
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A Prospective, Single-arm Study of the Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions Such as Fine Lines and for Improvement of Skin Quality

Conditions
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Skin Roughness

Intervention / Treatment
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* Device: VYC-12 HA injectable gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in good general health Score of 2=Moderate (coarse and uneven visual skin texture) or 3=Severe (coarse visual skin texture, crosshatched fine lines) on both cheeks using the 5-Point Allergan Skin Roughness Scale (ASRS). Exclusion Criteria: Has undergone tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg. face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face or neck within the past 12 months Has received any crosslinked HA filler in any anatomic area within the past 12 months Has undergone treatment with botulinum toxins in the face or neck within the past 6 months Has ever received semi-permanent fillers or permanent facial implants (eg. poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or neck Has facial hair that would interfere with the visualization of the face or neck Has undergone a dental procedure within the past 6 weeks Has a tendency to develop hypertrophic scarring Has a history of allergy to HA products and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria Has a history of anaphylactic shock Has been previously diagnosed with streptococcal disease (eg. recurrent sore throat, acute rheumatic fever) Has current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face or neck Is on an ongoing regimen of anticoagulation therapy (eg. warfarin) Is on an ongoing regimen of medications (eg. aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection Has begun using any over-the-counter or prescription, oral or topical, antiwrinkle products on the face or neck within the past 30 days.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VYC-12 Injectable Gel<br>VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection on Day 0 in the face and if applicable neck areas. Participants are eligible to receive up to 3 treatments including an optional top-up and an optional second treatment. | Device: VYC-12 HA injectable gel<br>* VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a ≥1 Point Improvement in the 5-Point Allergan Skin Roughness Scale (ASRS) compared to Baseline |  | Baseline, Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Instrument Measures of Cheek Skin Smoothness |  | Baseline, Month 1 | 
| Change from Baseline in Instrument Measures of Cheek Skin Hydration |  | Baseline, Month 1 | 
| Change from Baseline in Instrument Measures of Cheek Skin Elasticity |  | Baseline, Month 1 |