FDA approves injectable Skinvive for ‘tech neck’ lines and other wrinkles

Key takeaways:

  • Skinvive by Juvéderm is the first hyaluronic acid injectable approved for neck wrinkles.
  • It improves the appearance of neck lines by helping the skin retain moisture, softness and smoothness.

Origin Source: Healio.com

Perspective from Macrene Alexiades, MD, PhD, FAAD

"Today’s FDA approval of Skinvive by Juvéderm for the reduction of horizontal neck lines marks a significant milestone in aesthetic dermatology, and one I have had the privilege of contributing to directly as lead author and principal investigator of the pivotal clinical trial that established the foundational evidence base for this product.

Our randomized, multicenter, evaluator-blinded study, published in Dermatologic Surgery in 2023, evaluated the safety and effectiveness of VYC-12L for skin quality improvements and provided the clinical data that supported Skinvive by Juvéderm’s initial FDA approval for cheek skin smoothness.

The mechanism of action distinguishes this product categorically from traditional hyaluronic acid fillers. Rather than augmenting volume, VYC-12L is delivered as micro-droplets intradermally, where it restores the skin’s intrinsic capacity to retain moisture, resulting in measurably improved softness, hydration and smoothness. This is a fundamentally different therapeutic paradigm — one that addresses skin quality at the dermal level rather than structural contour.

The extension of this approval to horizontal neck lines is both scientifically logical and clinically timely. The neck has long been one of the most undertreated areas in aesthetic medicine, owing in part to the absence of FDA-approved injectable options specifically indicated for this anatomical zone.

Horizontal neck lines develop through a convergence of mechanisms: Intrinsic aging, actinic damage, weight fluctuation and, increasingly, the repetitive flexion posture associated with prolonged device use, now widely termed “tech-neck.” The prevalence of this presentation in my practice has grown substantially over the past decade, and the unmet need has been evident.

The pivotal data supporting this new indication are compelling. From my perspective as both a clinical investigator and a practicing dermatologist-scientist, several aspects of this approval warrant emphasis for providers considering incorporating this treatment into their practice.

First, patient selection and expectation-setting are paramount. Skinvive by Juvéderm addresses skin quality, including hydration, smoothness and texture, as opposed to structural laxity or platysmal banding. Patients presenting primarily with significant skin redundancy or muscle-related neck changes will require a multimodal approach, and Skinvive by Juvéderm should be understood as one tool within a broader neck rejuvenation strategy that may include radiofrequency, energy-based devices or neuromodulators, depending on the clinical picture.

Second, the FDA has appropriately required a provider training program prior to purchase and administration of Skinvive by Juvéderm for this new indication. I would strongly encourage all interested providers to complete this training rigorously. The neck presents unique anatomical considerations relative to the cheeks, and technique precision — including depth of injection, volume per depot and spacing — will be critical determinants of outcome and safety.

Third, it is worth noting that the safety and effectiveness of Skinvive by Juvéderm neck treatment has not been studied in patients with darker skin tones, a limitation that should inform patient counseling and underscores the need for continued research in more diverse populations.

The approval of Skinvive by Juvéderm for neck lines represents the maturation of a new category of aesthetic injectables, one grounded in skin biology rather than structural augmentation. As the field continues to evolve toward more nuanced, skin quality-driven approaches, this approval marks a meaningful inflection point. I am proud that the science generated in our pivotal trial has translated into a clinical tool that practitioners and patients can now access with the confidence of FDA approval."

Macrene Alexiades, MD, PhD, FAAD
  • Healio Dermatology Peer Perspective Board Member
  • Dermatology & Laser Center of New York

Disclosures: Alexiades reports receiving research grants from InMode, Lumenis and Candela, being a board advisor for SurgiVance and is founder/CEO Macrene actives.

 

 

The FDA approved Skinvive by Juvéderm for the treatment of neck wrinkles in adults aged 21 years or older, Allergan Aesthetics announced in a press release.

This approval makes Skinvive by Juvéderm (Allergan Aesthetics) the first and only hyaluronic acid injectable indicated to reduce the appearance of neck lines, according to the release.

There are many causes for neck wrinkles, including natural aging, sun damage, weight loss, or the modernly coined term “tech-neck,” where lines form in the neck region due to constantly looking down at computers, phones, tablets and books. According to the release, Skinvive by Juvéderm can improve the appearance of wrinkles from “tech-neck” by helping the skin retain its natural moisture, softness and smoothness.

The approval of Skinvive by Juvéderm was supported by a randomized, multicenter, evaluator-blinded, controlled clinical trial, where 74.8% of 105 participants treated with Skinvive by Juvéderm for neck wrinkles saw a 1-point or higher improvement on the 5-grade photonumeric Allergan Transverse Neck Lines Scale at 1 month, according to the release. More than 65% of participants maintained this improvement through 6 months, and over 78% demonstrated improvement in overall score from baseline at each of the study’s timepoints.

Adverse events from Skinvive by Juvéderm included redness, bruising, tenderness, lumps and bumps, swelling, firmness, pain, discoloration and itching at the injection sites, according to the participants’ electronic diaries kept during the study. Because the adverse events were mild, caused little discomfort and did not impede daily activities, they did not require treatment and resolved within 2 weeks, according to the release. Of 147 participants, seven experienced severe adverse events, which occurred at similar or less frequent rates after touch-ups and repeat treatments.

The study did not evaluate the use of Skinvive by Juvéderm in people with darker skin tones, the company stated.

Because Skinvive by Juvéderm is a novel product, the FDA requires that all providers who want to use this injectable undergo Allergan Aesthetics’ pending training program.


What to know about FDA approval of Skinvive by Juvéderm:

  • It is the first injectable hyalurolnic acid indicated to reduce appearance of neck lines. 
  • it was first approved in 2023 to improve skin smoothness of cheeks in adults
  • The FDA requires clinicians undergo a pending training program prior to use

Source: Healio Press Release