FDA Approves Skinvive by Juvéderm for Neck Wrinkles: Study
The FDA has approved Skinvive by Juvéderm for the treatment of neck wrinkles in adults aged 21 years and older, making it the first hyaluronic acid injectable specifically approved for this indication. Developed by Allergan Aesthetics, Skinvive works by enhancing the skin’s ability to retain moisture, thereby improving softness, smoothness, and the appearance of neck lines. The approval expands nonsurgical treatment options for neck rejuvenation and offers a targeted approach to addressing age-related skin changes in the neck area.
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.1 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.
"The approval of SKINVIVE by JUVÉDERM® for horizontal neck wrinkles reflects Allergan Aesthetics' commitment to developing science-driven innovations that address meaningful unmet aesthetic needs," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "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.
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.2 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.1 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.
As with some novel products, 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.
Optimal treatment with SKINVIVE by JUVÉDERM® may require an optional touch-up one month after initial treatment to achieve the desired aesthetic outcome and is dependent on patient need.
The safety and effectiveness of SKINVIVE by JUVÉDERM® neck treatment has not been studied in darker skin tone patients.
