JUVEDERM® SKINVIVE

Description

Manufacturer: Allergan
Active Substance(s): HYALURONIC ACID (HA), LIDOCAINE
Strength: 12mg/ml
Pack Size: 2 x 1ml pre-filled syringe(s) + 4 needles 32G-1/2″

For practitioners evaluating Skinvive Juvederm® before-and-after outcomes, the primary clinical focus is on improvement in cheek skin smoothness. Juvederm® Skinvive is an FDA-approved hyaluronic acid gel implant from Allergan Aesthetics, an AbbVie company, indicated for intradermal injection to improve cheek skin smoothness in adults aged 21 and older. Practitioners looking to buy Juvederm® Skinvive may contact Maylips for product guidance and availability.

Skinvive by Juvederm® is an FDA-approved hyaluronic acid injectable specifically indicated to improve cheek skin smoothness. It received FDA approval in May 2023 and is classified as a gel implant. This regulatory device designation refers to Skinvive’s injectable HA matrix rather than to a physical prosthetic.

Unlike a conventional dermal filler, Skinvive is not intended to lift, contour, or restore structural volume. Its clinical objective is intradermal hydration and improved skin texture. It is manufactured by Allergan Aesthetics and is intended for use by trained, licensed medical professionals.

In CE-marked international markets, the same base formulation is available as Juvederm® Volite, with an indication scope varying by region. Practitioners should verify local prescribing information and current regulatory status before use. (Regulatory information current as of May 2026.)

Product Specifications

• Active ingredient: Hyaluronic acid (HA); cross-linked microdroplet formulation (VYC-12L; 12 mg/mL HA + 0.3% lidocaine)
• Product type: Injectable HA gel; intradermal delivery
• Format: Prefilled syringe for professional administration
• Manufacturer: Allergan Aesthetics, an AbbVie company
• Regulatory status: FDA-approved (2023) for improvement of cheek skin smoothness
• Indication: Improvement of skin smoothness of the cheeks in adults over 21
• CAS number: Hyaluronic acid CAS 9004-61-9; lidocaine CAS 137-58-6
• Storage: 2–25°C; protect from freezing and direct sunlight
• Intended use: Rx-only; for use by trained healthcare professionals

• Indication-specific FDA approval: FDA-approved to improve cheek skin smoothness. Skinvive is not a repurposed volumizing filler
• Microdroplet delivery system: Small-volume HA deposits distributed diffusely across the cheek dermis, supporting uniform intradermal hydration
• Cross-linked HA matrix: BDDE cross-linking provides resistance to enzymatic degradation, extending persistence beyond non-cross-linked HA solutions
• Skin quality focus: Designed to improve smoothness and hydration; not intended for volumizing or contouring
• Lidocaine-enhanced formulation:3% lidocaine supports patient comfort during administration
• Established clinical evidence: Efficacy and safety supported by the pivotal US clinical trial and a European prospective study of the VYC-12 formulation
• Complementary protocol: Does not replace volumizing or contouring treatments; intended for patients with intact facial structure and compromised skin quality

Skinvive works by delivering cross-linked hyaluronic acid into the dermis, where HA molecules attract and retain water within the extracellular matrix. This restores dermal hydration and supports smoother cheek skin texture at the tissue level. The microdroplet technique places small, evenly distributed deposits throughout the cheek dermis, supporting a more uniform texture.

BDDE cross-linking extends the degradation time of the HA matrix compared with non-cross-linked formulations, maintaining the hydration effect over time. While not designed to provide structural volume or contouring, mild visual plumping may occur due to increased hydration within the dermal matrix. Clinical outcomes are primarily associated with smoother-appearing skin.

Appropriate candidates present with dull skin texture, crepey facial tissue, or reduced face smoothness without significant volume loss. Before treatment, practitioners should assess patient suitability, allergy history, and recent procedures. Treatment should be deferred in the presence of active infection, inflammatory lesions, or skin disruption in the target area.

Pivotal US Trial

In the pivotal US clinical study (Alexiades M et al., Dermatol Surg. 2023) — a randomized, multicenter, evaluator-blind, controlled trial — 57.9% of treated participants achieved at least a 1-point improvement on the Allergan Cheek Smoothness Scale (ACSS) at one month compared with 4.5% in the no-treatment control group (p < 0.001). 55.6% maintained this response at six months. Among participants who received repeat treatment at six months, the responder rate was 68.5% at one month post-repeat.

Patient-Reported Outcomes

Patient-reported outcomes from the same study (Chiu A et al., Aesthet Surg J. 2023) demonstrated marked improvements in skin satisfaction: FACE-Q Satisfaction with Skin scores increased from a mean of 34.9 at baseline to 66.8 at one month and 60.2 at six months. At one month, 78.4% of participants reported satisfaction with how hydrated their skin looked compared with 23.7% at baseline, and 74.4% were satisfied with skin radiance compared with 11.1% at baseline.

European Prospective Study

A European prospective study of VYC-12 without lidocaine (Niforos et al., 2019) demonstrated comparable improvements in skin topography, fine lines, and hydration, with effects observed through 9 months following repeat treatment — consistent with longer maintenance intervals observed in international markets under the Volite designation.

Skinvive Juvederm® before and after improvements are characterized by improvements in cheek skin smoothness and overall skin quality, not changes in facial volume or contour. Moreover, pivotal US data found that Skinvive delivers improvements over six months, with maintenance treatment typically determined by patient response.

Store at 2–25°C. Protect from freezing and direct sunlight. Maintain expiration compliance and observe all sterility requirements. Full prescribing information should be reviewed prior to administration.

In terms of safety, the most clinically significant risk is unintentional intravascular injection, which is rare but may cause vision abnormalities, blindness, stroke, tissue necrosis, or permanent scarring. Appropriate training and readiness to manage complications, including access to hyaluronidase, are essential.

Common adverse effects are consistent with the HA filler class and are generally mild and transient. They are typically the following:

• Swelling
• Bruising
• Erythema
• Tenderness
• Injection-site discomfort

Additional risks include delayed inflammatory reactions, hypersensitivity events, and increased bruising in patients taking aspirin, NSAIDs, or anticoagulants. Contraindications include hypersensitivity to hyaluronic acid or lidocaine and active infection or inflammation at the treatment site.

1. Alexiades M, Palm MD, Kaufman-Janette J, et al. A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements. Dermatol Surg. 2023;49(7):682-688. doi:10.1097/DSS.0000000000003802
2. Chiu A, Montes JR, Munavalli G, Shamban A, Chawla S, Abrams S. Improved Patient Satisfaction With Skin After Treatment of Cheek Skin Roughness and Fine Lines With VYC-12L: Participant-Reported Outcomes From a Prospective, Randomized Study. Aesthet Surg J. 2023;43(11):1367-1375. doi:10.1093/asj/sjad111
3. Niforos F, Ogilvie P, Cavallini M, et al. VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. Clin Cosmet Investig Dermatol. 2019;12:791-798. Published 2019 Oct 24. doi:10.2147/CCID.S216222
4. Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009;35 Suppl 1:302-312. doi:10.1111/j.1524-4725.2008.01046.x
5. US Food and Drug Administration. SKINVIVE by JUVÉDERM – P110033/S059. US Food and Drug Administration. May 11, 2023. Updated July 10, 2023. https://www.fda.gov/medical-devices/recently-approved-devices/skinvive-juvederm-p110033s059