Juvederm SkinVive 2x1ml

• Cross-linked hyaluronic acid gel: 12.0 mg per ml, of non-animal origin. It is the lowest concentration in the entire Juvéderm® range.
• Lidocaine hydrochloride: 3.0 mg per ml (0.3 %), included to reduce patient pain during treatment.
• Phosphate buffer pH 7.2 q.s. to 1 ml (or g).
• Sterile, pyrogen-free physiological solution in a graduated single-use pre-filled syringe.
• VYCROSS® technology: SKINVIVE™ corresponds to the VYC-12 gel of the VYCROSS® platform, which combines high- and low-molecular-weight hyaluronic acid. The low concentration combined with high cross-linking efficiency produces a very fluid gel with low water uptake, designed to be placed in intradermal microdeposits without generating a volumising effect.

SKINVIVE™ is the only product in the Juvéderm® range that does not aim at volumetric correction: its objective is skin quality — hydration, elasticity and texture — and not the filling of a structural defect.

Note on the designation: SKINVIVE™ by Juvéderm® is the name under which Allergan Aesthetics has globally unified the product marketed in Europe as Juvéderm® VOLITE™. The formulation is identical — VYCROSS® HA 12 mg/ml, lidocaine 3 mg/ml, 2 syringes of 1 ml and 4 needles of 32G ½" — and the current instructions for use (2024 revision) are already issued under the SKINVIVE™ designation.

When to choose SKINVIVE™ over its neighbours: compared with VOLBELLA® (15 mg/ml), when the objective is the skin surface rather than a specific depression to be filled, and when treatment is planned as microdeposits over a broad area. Compared with the ULTRA gels (24 mg/ml, HYLACROSS™) the difference is one of category: SKINVIVE™ provides neither projection nor structural support and is not indicated for the lips or for deep folds.

Injectable implant indicated for the treatment, by filling, of superficial cutaneous depressions such as fine lines, and for the additional improvement of skin quality attributes such as hydration and elasticity.

• Fine lines and superficial cutaneous depressions
• Skin hydration and elasticity

Route: the product is intended for intradermal injection by a practitioner authorised in accordance with applicable local regulations.

Contraindicated areas: do not inject into the eyelids. It is not indicated for breast augmentation or reconstruction.

• Route of administration: intradermal injection only.
• Needles included: 4 units of CE-marked 32G ½", sterilised by irradiation. The manufacturer accepts the TSK 32G 3/16" needle (ref. PRE-32004) as an alternative; the choice of length is for the practitioner according to their technique.
• Technique: intradermal microdeposits distributed evenly. The area to be treated must be thoroughly disinfected; in treatments over a broad surface, the complete area should be considered (for example, the whole face).
• Injector profile: the manufacturer restricts use to practitioners trained and experienced in injection techniques for the treatment of superficial cutaneous depressions and with knowledge of the anatomy of the area.
• Aspiration beforehand: after inserting the needle and before injecting, it is recommended to withdraw the plunger slightly to verify that the needle is not intravascular.
• Immediate blanching: stop the injection and massage the area until normal colour returns.
• Inject slowly and with the minimum pressure necessary. If the needle becomes blocked, do not increase pressure on the plunger: stop the injection and replace the needle.
• Manufacturer's annual limit: no safety data are available for the injection of more than 20 ml of Allergan dermal fillers per 60 kg of body weight per year.
• Interval between sessions: wait for side effects to resolve, with a minimum interval of 2 weeks between two injections.
• Do not overcorrect: injecting an excessive volume may cause tissue necrosis and oedema.
• Documented duration: prospective study of the VYC-12 gel with 131 subjects treated by intradermal microdeposits with a 32G needle (median total volume 3.9 ml): 96.2 % responders in skin roughness (ASRS scale) at month 1 and 76.3 % at month 4; significant improvement in skin hydration maintained up to month 9 (Niforos F. et al., Clin Cosmet Investig Dermatol 2019;12:791–798). In the pivotal study registered with the FDA for the cheek skin smoothness indication: 57.9 % responders versus 4.5 % in the control group at month 1 (p < 0.001) and 55.6 % maintaining the response at 6 months.
• Aftercare: no make-up for the following 12 hours; avoid prolonged exposure to the sun and to UV rays, temperatures below 0 °C, sauna and hammam for the following two weeks.

• Storage: between 2 °C and 25 °C. Fragile product. Do not use after the expiry date stated on the label.
• Do not use the syringe if the contents show signs of separation or a cloudy appearance.
• Single-use product. Do not reuse or re-sterilise: sterility cannot be guaranteed after reuse.
• Sterilisation: syringe contents by moist heat; needles by irradiation.
• The pack includes: 2 pre-filled syringes of 1.0 ml, 4 sterile needles of 32G ½", instruction leaflet and a set of traceability labels.
• Used needles must be disposed of in appropriate containers; never straighten a bent needle.

Contraindications: untreated epilepsy; tendency to hypertrophic scarring; known hypersensitivity to hyaluronic acid or to Gram-positive bacterial proteins (the HA is obtained from bacteria of the genus Streptococcus); hypersensitivity to lidocaine or to amide-type local anaesthetics; porphyria; pregnancy and breastfeeding; minors. Do not inject into areas with inflammatory or infectious skin processes (acne, herpes). Do not inject intravascularly. Do not overcorrect.

Incompatibilities: hyaluronic acid is incompatible with quaternary ammonium salts such as benzalkonium chloride; avoid all contact with these substances or with instruments treated with them. No interactions with other local anaesthetics are known.

Precautions and individual assessment: there are no clinical data on efficacy and tolerance in patients with autoimmune disease, immunodeficiency or immunosuppressive therapy, nor in patients with a history of severe or multiple allergies — the indication is assessed case by case and a prior skin test is recommended; in case of a history of anaphylactic shock, it is recommended not to inject. Patients with a history of streptococcal disease (recurrent pharyngitis, acute rheumatic fever) should undergo a prior skin test. Warn patients on anticoagulant or antiplatelet therapy of the increased risk of bleeding and bruising. Because of the presence of lidocaine, combination with drugs that reduce or inhibit hepatic metabolism (cimetidine, beta blockers) is not recommended, and caution is advised in patients with cardiac conduction disorders.

Do not use simultaneously with laser, deep chemical peels or dermabrasion. With superficial peels, do not inject if the inflammatory reaction generated is significant.

Vascular risk: serious adverse events have been reported in association with intravascular injection of facial dermal fillers — temporary or permanent visual impairment, blindness, cerebral ischaemia or haemorrhage with stroke, skin necrosis and injury to underlying structures. Stop the injection immediately in the event of any visual change, sign of stroke, skin pallor or unusual pain.

Always consult the instructions for use enclosed in the packaging before application.