Actual patient. Results may vary.
The hyaluronic acid (HA) in SKINVIVE by JUVÉDERM® improves cheek skin smoothness, and helps skin look hydrated, healthy, and glowing. Treatment also increased hydration within the dermis, with results seen as early as month 1.1
Hydration is an important component of skin quality2
Patients have a variety of skin quality options, but there is an opportunity in the category for a convenient treatment that provides lasting smoothness, hydrates the skin from within, and does not require a series of treatments.1
Increased skin hydration has been shown to increase smoothness of the skin3
Hydration at the dermal level is essential for keeping the skin plump, elastic, and resilient, but you also need epidermal hydration to maintain the skin’s barrier function, maintain its integrity, and prevent the appearance of dry skin. SKINVIVE® is the first and only HA microdroplet injectable indicated to improve skin smoothness of the cheeks.1,4,5
Improvements in attributes of skin quality
Aquaporin-3 is a protein that facilitates the flow of water and glycerol into and out of cells. Glycerol plays an important role in hydration of the skin, in providing elasticity, and in facilitating epidermal barrier repair. In a European postmarketing open-label study, SKINVIVE®-treated volar forearm skin showed measurable increases in hydration in the surface of the skin and within the skin, as measured by objective hydration probes.9,10
Histological changes were studied for 3 months in healthy volunteers (N = 11) with Fitzpatrick skin types II and III only.10 No conclusions regarding treatment with SKINVIVE by JUVÉDERM® can be drawn based on these observations.
See SKINVIVE by JUVÉDERM® clinical results
References: 1. SKINVIVE® by JUVÉDERM® Directions for Use, 2023. 2. Humphrey S, et al. Defining skin quality: clinical relevance, terminology, and assessment. Dermatol Surg. 2021;47(7):974-81. 3. Dabrowska AK, Adlhart C, Spano F, et al. In vivo confirmation of hydration-induced changes in human-skin thickness, roughness and interaction with the environment. Biointerphases. 2016;11(3):031015. 4. SKINVIVE® by JUVÉDERM® Press Release, May 2023. 5. Draelos Z. Aquaporins: an introduction to a key factor in the mechanism of skin hydration. J Clin Aesthet Dermatol. 2012;5(7):53-56. 6. Narurkar VA, Fabi SG, Bucay VW, et al. Rejuvenating hydrator: restoring epidermal hyaluronic acid homeostasis with instant benefits. J Drugs Dermatol. 2016;15(1):s24-37. 7. Tendler A. Microdermabrasion with Serum Infusion: Enter Fall Looking Your Best. Artisan Skin and Laser Center. August 18, 2016. Accessed May 18, 2022. https://artisanskinandlaser.com/blog/microdermabrasion-with-serum-infusion-enter-fall-looking-your-best 8. Baumann L. Skin ageing and its treatment. J Pathol. 2007;211:241-251. 9. Tandon. Different treatment modalities for skin quality. Allergan Aesthetics. 2021. 10. Safa M, Natalizio A, Kee CK. A prospective, open-label study to evaluate the impact of VYC-I2L injection on skin quality attributes in healthy volunteers. Clin Cosmet Investig Dermatol. 2022;15:411-426.
INDICATIONS
SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGS
- Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
- Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
- Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
- To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
- Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
- Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
- This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
- Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
- As with all transcutaneous procedures, injections of the product carry a risk of infection
- The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
- The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
- This product should be used with caution in patients on immunosuppressive therapy
- Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
- Patients may experience late onset AEs with use of injectable gel implants, including this product
- This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
- If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE by JUVÉDERM®, please call the Allergan® Product Support Department at 1-877-345-5372. Please see Directions for Use for more information.
SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
INDICATIONS
SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGS
- Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
- Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
- Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
- To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
- Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
- Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
- This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
- Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
- As with all transcutaneous procedures, injections of the product carry a risk of infection
- The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
- The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
- This product should be used with caution in patients on immunosuppressive therapy
- Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
- Patients may experience late onset AEs with use of injectable gel implants, including this product
- This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
- If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE by JUVÉDERM®, please call the Allergan® Product Support Department at 1-877-345-5372. Please see Directions for Use for more information.
SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.