Clinical trial results showed improvements in neck appearance lasting up to six months following treatment.
Allergan Aesthetics, an AbbVie company, announced the US Food and Drug Administration (FDA) approval of Skinvive by Juvederm to reduce neck lines for the improvement of neck appearance in adults over the age of 21.
Neck wrinkles may develop due to natural aging, sun damage, weight loss, or “tech-neck” caused by the head-down position used for phones, tablets, and books. Skinvive by Juvederm reduces neck lines formed by tech-neck by helping the skin retain its natural moisture, softness, and smoothness, according to a release from Allergan Aesthetics. Treatment with Skinvive by Juvederm 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.
“This approval expands our portfolio of lower face and neck treatment options and gives patients and aesthetic providers a first-of-its-kind treatment option for improving neck skin quality and reducing the appearance of neck lines,” says Darin Messina, PhD, senior vice president of aesthetics research and development at AbbVie, in a release.
Clinical Study Results
In the randomized, multicenter, evaluator-blinded, controlled pivotal clinical study, 74.8% (78.5/105) of participants treated in the neck with Skinvive by Juvederm saw clinically significant (≥ 1 point) improvement on the validated 5-grade photonumeric Allergan Transverse Neck Lines Scale 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 (AEs) such as redness, bruising, tenderness, lumps/bumps, swelling, firmness, pain, discoloration, and itching at the injection sites, as reported in their electronic diaries. These AEs were usually mild (causing little discomfort and no effect on daily activities), did not require treatment, and resolved within two weeks. Severe AEs were experienced by less than 5% of participants (7/147 reporting AEs). These AEs 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 Juvederm. Allergan Aesthetics anticipates that Skinvive by Juvederm for the improvement of neck appearance will be broadly commercially available later this year.
This is the second FDA-approved indication for Skinvive by Juvederm, which has been approved since 2023 to improve skin smoothness of the cheeks in adults.
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