お知らせ • Jun 16
Allergan Aesthetics Receives Fda Approval for Skinvive by Juvederm for Improvement of Neck Appearance
Allergan Aesthetics, an AbbVie company, announced the U.S. Food and Drug Administration approval of SKINVIVE by JUVÉDERM to reduce neck lines for the improvement of neck appearance in adults over the age of 21. SKINVIVE by JUVÉDERM is the first and only hyaluronic acid injectable indicated to reduce the appearance of neck wrinkles and help skin retain its natural moisture, leading to an improved neck appearance. SKINVIVE by JUVÉDERM reduces neck lines formed by tech-neck by helping the skin retain its natural moisture, softness, and smoothness. Treatment with SKINVIVE by JUVÉDERM is minimally invasive with little to no downtime and is administered using an ultrafine needle or cannula. The product contains a small amount of local anesthetic (lidocaine) to support patient comfort during treatment. Results last six months with optimal treatment. In the randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 74.8% (78.5/105) of participants treated in the neck with SKINVIVE by JUVÉDERM saw clinically significant (= 1 point) improvement on the validated 5-grade photonumeric Allergan Transverse Neck Lines Scale (ATNLS) at one month. Most participants (66% or 64/97) maintained = 1 point improvement in horizontal neck lines at six months. Participants who demonstrated improvement from baseline in overall score stayed high (=78%) at all timepoints during the study. Participants in the clinical study reported experiencing adverse events such as redness, bruising, tenderness, lumps/bumps, swelling, firmness, pain, discoloration, and itching at the injection sites, as reported in their electronic diaries. These adverse events were usually mild (causing little discomfort and no effect on daily activities), did not require treatment, and resolved within two weeks. Severe adverse events were experienced by less than 5% of participants (7/147 reporting adverse events). These adverse events were reported similarly or less frequently after touch-ups and repeat treatments. The FDA has required that Allergan Aesthetics provide a training program for all interested providers. Successful completion of this training is necessary prior to purchase of and administration of SKINVIVE by JUVÉDERM. Allergan Aesthetics anticipates that SKINVIVE by JUVÉDERM for the improvement of neck appearance will be broadly commercially available later this year. SKINVIVE by JUVÉDERM injectable gel is an injection to improve skin smoothness of the cheeks in adults over the age of 21. SKINVIVE by JUVÉDERM injectable gel is an injection to reduce neck lines for improvement of neck appearance in adults over the age of 21. One of the risks with dermal filler injections is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible. The use of this product where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse. The effectiveness of removal of any dermal filler has not been studied. Avoid applying makeup for 12 hours after treatment. Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site. Tell your specialist if you are using any medication that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site. Tell your specialist if you are planning laser treatment, chemical peeling, or any other procedure after SKINVIVE by JUVÉDERM. There is a possible risk of an inflammatory reaction at the treatment site. This product is intended for improving skin smoothness of the cheeks and reducing neck lines. The safety and effectiveness for treatment in other areas of the body have not been established. Tell your specialist if you are on therapy used to decrease the body's immune response, as treatment may result in an increased risk of infection. Tell your specialist if you are pregnant or breastfeeding. The safety for use during pregnancy, or in women who are breastfeeding, has not been studied. Tell your specialist if you have a history of excessive scarring (thick, hard scars). The safety of this product in patients with a history of excessive scarring has not been studied and may result in additional scars. Tell your specialist if you have a history of pigmentation disorders, as use of this product in patients with a history of pigmentation disorders has not been studied and may result in changes in pigmentation. The most commonly reported side effects were redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration and itching. Most side effects will resolve within 2 weeks. If they persist longer, your physician may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase. Additionally, there have been reports of inflammation, nodules, unsatisfactory result, loss or lack of improvement, allergic reaction, anxiety, blood vessel blockage, infection, dry skin, increase or decrease in sensation, and abscess. Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. As with all skin injection procedures, there is a risk of infection. SKINVIVE by JUVÉDERM is available only by a licensed physician or properly licensed practitioner.