SKINVIVE by JUVÉDERM
Juvederm
Derma fillersHyaluronic acid microdroplet skin quality injectable / skin booster
Certifications
- CE Marked Class III medical device in applicable international markets for the treatment of superficial cutaneous depressions and improvement of skin quality attributes such as hydration and elasticity
- FDA Approved hyaluronic acid microdroplet injectable dermal filler in the United States (PMA supplement P110033/S059) for improving cheek skin smoothness in adults over 21
- Manufactured under a medical Device quality management system compliant with relevant international standards and regulatory requirements for HA injectable implants
- CE Marked Class III medical device in applicable international markets for the treatment of superficial cutaneous depressions and improvement of skin quality attributes such as hydration and elasticity
- FDA Approved hyaluronic acid microdroplet injectable dermal filler in the United States (PMA supplement P110033/S059) for improving cheek skin smoothness in adults over 21
- Manufactured under a medical Device quality management system compliant with relevant international standards and regulatory requirements for HA injectable implants
Hyaluronic acid microdroplet skin quality injectable / skin booster
Description
SKINVIVE by JUVÉDERM is a hyaluronic acid (HA) microdroplet injectable gel designed to improve cheek skin smoothness and overall skin quality. Using a modified form of HA combined with lidocaine for comfort, SKINVIVE increases dermal hydration and helps the skin retain its natural moisture, resulting in smoother, more radiant, healthy-looking skin. It is indicated for intradermal injection into the cheeks in adults over 21 years of age and, in broader marketing descriptions, is also promoted for deep hydration and improvement of texture and radiance in the face, neck, hands and décolletage.
Bnefits
- First and only hyaluronic acid microdroplet injectable in the US specifically indicated to improve cheek skin smoothness
- Improves skin hydration, texture, elasticity and radiance for a healthier-looking glow
- Provides long-lasting improvement in skin smoothness and glow, with clinical data supporting results for at least 6 months with optimal treatment, and some international materials referencing up to 9 months of deep hydration with a single treatment course
- Microdroplet injection technique distributes HA evenly in the superficial dermis without creating volume or altering facial contours
- Contains lidocaine to reduce injection-site pain and improve patient comfort during treatment
- Suitable for a wide range of skin tones and types as demonstrated in clinical studies
- Can be combined with other aesthetic treatments (e.g., traditional fillers or botulinum toxin) as part of a comprehensive rejuvenation plan, according to clinician judgement
Indications
- Intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21
- Enhancement of overall skin quality attributes such as hydration, elasticity and radiance in the treated areas
- Treatment of superficial cutaneous depressions such as fine lines in appropriately selected patients
- Use as a skin-quality booster (rather than volumising filler) in individuals seeking improved glow and skin texture without significant change in facial contours
Composition
- Hyaluronic acid gel: 12.0 mg per 1 mL syringe (stabilised/modified form of non-animal HA produced by bacterial fermentation)
- Lidocaine hydrochloride monohydrate: 3 mg per 1 mL syringe (0.3% lidocaine) to reduce injection-site pain
- Phosphate buffer, pH ~7.2, and water for injection to make 1 mL
- Contains the crosslinking agent 1,4-butanediol diglycidyl ether (BDDE) as part of the HA modification process (residual BDDE within accepted safety limits)
Formulation
- Sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colourless, homogeneous HA gel
- HA concentration: 12 mg/mL with 0.3% lidocaine
- Stabilised/modified HA designed for intradermal microdroplet injection into the cheeks
- Intended for intradermal use with an ultra-fine needle using a microdroplet grid pattern to treat the superficial dermis
- Delivered as prefilled single-use glass syringes with luer-lock connections and supplied with appropriate single-use needles
- Class III medical device in many international markets; FDA-approved HA dermal filler in the United States
Packaging
- Standard commercial pack: 2 x 1 mL prefilled syringes of SKINVIVE by JUVÉDERM injectable gel per box (e.g., DD Group product code 600267: "2 x 1.0 ml")
- Each syringe supplied sterile in a blister tray, accompanied by single-use sterile needles suitable for intradermal injection
- Outer carton printed with product name, volume, batch number, expiry date, CE/FDA markings (depending on market), manufacturer details and instructions for use
- Includes patient/physician information leaflets and detachable traceability labels for clinical records
Usage
- For use only by appropriately trained and licensed healthcare professionals experienced in dermal filler and skin-quality injection techniques.
- Before treatment, obtain full medical history, assess indications and rule out contraindications; obtain informed consent.
- Cleanse and disinfect the treatment area thoroughly following local aseptic protocols; consider topical anaesthesia if needed, in addition to the lidocaine contained in the product.
- Inject SKINVIVE by JUVÉDERM intradermally into the cheeks using an ultrafine needle and a microdroplet (grid) injection technique, placing small aliquots of gel in the superficial dermis over the target area.
- Inject slowly with low pressure to minimise discomfort and reduce the risk of vascular compromise; aspirate in accordance with current clinical best practice and injector training.
- Do not overcorrect; aim for uniform distribution of microdroplets to improve skin smoothness and hydration rather than volumisation.
- After injection, gently massage the treated area if required to ensure even distribution and smooth contour.
- Post-treatment advice typically includes avoiding makeup for several hours, intense heat exposure (saunas, sunbeds), vigorous exercise and alcohol for 24 hours, and using broad-spectrum sun protection.
- Dispose of used syringes, needles and any leftover product in approved sharps and clinical waste containers; SKINVIVE is single-use only and must not be resterilised or reused.
Contraindications
- Severe allergies characterised by a history of anaphylaxis or multiple severe allergies
- Known hypersensitivity to hyaluronic acid, lidocaine, amide-type local anaesthetics, or Gram-positive bacterial proteins
- Presence of active skin infections, inflammation, or disease (e.g., herpes, dermatitis) at or near the intended injection sites
- History of allergy or hypersensitivity to products containing lidocaine or other components of the formulation
- Patients with bleeding disorders or those on significant anticoagulant/antiplatelet therapy, unless the risk–benefit is carefully evaluated
- Pregnancy and breastfeeding (use generally not recommended due to limited safety data)
- Injection into blood vessels or in areas with compromised vascularity; intravascular injection can lead to serious complications
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, firmness, lumps/bumps, pain, tenderness, bruising, itching, or discolouration at the treatment area
- Temporary dryness or surface irregularities at the injection sites
- Rare inflammatory reactions, nodules or granuloma formation which may require medical management
- Very rare but serious adverse events related to inadvertent intravascular injection, such as vascular occlusion, tissue necrosis, or visual disturbances, as with other HA fillers
- Potential allergic or hypersensitivity reactions to hyaluronic acid, lidocaine or other excipients
- As with any injection procedure, a small risk of infection exists if aseptic technique is not strictly followed
Storage Conditions
- Store in the original packaging at controlled room temperature according to the manufacturer’s label (typically between 2 °C and 25 °C, not frozen).
- Protect from freezing and from excessive heat or direct sunlight.
- Keep syringes in their sealed blister packs until immediately before use to maintain sterility.
- Do not use the product after the expiry date printed on the outer carton and syringe label.
- Discard any syringe that shows evidence of package damage, contamination, or physical compromise of the gel.
Duration
Clinical studies and manufacturer information support improvement in cheek skin smoothness and glow for at least 6 months with optimal treatment; some international promotional material states up to 9 months of deep skin hydration from a single treatment course. Maintenance treatments are commonly performed approximately every 6\u20139 months depending on individual response and clinic protocol.
Onset
Initial improvement in skin hydration and radiance may be noticed within a few days to several weeks after treatment, with optimal improvement in cheek skin smoothness typically observed around 1 month post-treatment and maintained for several months thereafter.
