On June 11, 2026, FDA approved PMA supplement P110033/S099 (panel-track; labeling change — indications/instructions/shelf life/tradename) for SKINVIVE by JUVÉDERM. The approval-order statement is specific: intradermal injection to improve skin smoothness of the cheeks and intradermal and/or subdermal injection to reduce neck lines for improvement of neck appearance in adults over 21. Manufacturer and trade press call this the first hyaluronic-acid injectable with a US neck-lines indication. It is not a neck lift, not platysma denervation, and not a submental-fat treatment.
Off-label HA in the neck existed before S099. The change is on-label status and a US trial identity, not the invention of neck injection.
Direct Summary: Skinvive Neck Indication at a Glance
| Metric / Parameter | FDA Regulatory & Clinical Specification |
|---|---|
| Product Trade Name | SKINVIVE by JUVÉDERM (Allergan Aesthetics / AbbVie) |
| Active Ingredient | Modified Hyaluronic Acid Gel (12 mg/mL) with 0.3% Lidocaine HCl |
| FDA Approval Category | Class III Medical Device Premarket Approval (PMA) Supplement |
| PMA Supplement Number & Date | P110033/S099 (Approved June 11, 2026) |
| Prior Indications | P110033/S059 (Approved May 11, 2023; Cheek skin smoothness) |
| Official expanded indication (approval-order statement) | Intradermal injection to improve cheek smoothness and intradermal and/or subdermal injection to reduce neck lines for improvement of neck appearance, adults over 21 |
| Material limit (manufacturer) | Neck treatment has not been studied in darker skin tone patients (AbbVie press footnote) |
| US Registration Trial | NCT05316233 (Juvéderm Volite XC Neck Study, N=159; Completed Sept 12, 2024) |
| International Contrast Trial | NCT05741034 (China Volite Transverse Neck Lines Study, N=159; Not the US PMA study) |
| Primary Efficacy Endpoint | ≥ 1-grade improvement on the Allergan Transverse Neck Lines Scale (ATNLS) at Month 1 |
| Reported Clinical Durability | 74.8% responders at Month 1; 66.0% responders at Month 6; labeled for up to 6 months duration |
| Anatomical Exclusions | Does NOT treat vertical platysma bands, submental fat pads, or severe surgical laxity |
| Typical Injected Volume | 1 to 2 syringes (1.0 mL to 2.0 mL total) per neck treatment session |
| Average Out-of-Pocket Cost | $700–$1,600 per session ($723/syringe national survey benchmark) |
Is Skinvive FDA-Approved for the Neck, and What Is P110033/S099?
Yes. As of June 11, 2026, Skinvive is formally FDA-approved for improving neck appearance and horizontal neck lines in adults over 21.
To understand the regulatory significance of this approval, one must examine the FDA Premarket Approval (PMA) supplement history of the P110033 regulatory docket (product code LMH, 21 CFR 878.3540):
- P110033/S059 (May 11, 2023): initial US Skinvive indication — intradermal cheek smoothness.
- P110033/S097 (May 1, 2025): Special (immediate track) labeling change. The approval-order statement is updates to postmarket surveillance data in the patient labeling and DFU — not a packaging-spec change, and not the neck indication.
- P110033/S099 (June 11, 2026): panel-track supplement; FDA received May 13, 2025. This is the neck-lines indication. The PMA listing names NCT05316233 as the supporting trial.
The skin-booster regulatory index now records S099 alongside S059. The anatomy explainer is tech neck / horizontal neck lines.
Which Clinical Trial Is the US PMA Study: NCT05316233 vs NCT05741034?
The US PMA study is NCT05316233, not the China Volite study NCT05741034.
- NCT05316233: JUVÉDERM VOLITE XC for neck appearance; 159 actual participants; United States (15 sites); randomized, evaluator-blinded; completed September 12, 2024. Inclusion required ATNLS grade 2 or 3. FDA’s S099 listing names this NCT. Primary effectiveness: ATNLS ≥1-grade improvement at month 1. Pregnant or nursing people were excluded.
- NCT05741034: same n=159, China sites, primary ATNLS assessment at month 2, completed December 9, 2024. It is a parallel China program, not the US PMA docket.
Do not cite NCT05741034 as “the FDA study.” Do not assume the two datasets can be pooled from the registry pages alone.
What Did the Neck Trial Actually Measure, and How Durable Are the Results?
Understanding clinical trial endpoints allows patients to separate genuine biological improvements from exaggerated marketing claims.
ATNLS is a 5-point photonumeric scale (registry language: 0 = none, 4 = extreme). A responder needed at least a 1-grade improvement on blinded investigator live assessment. This page does not invent prose for grades 1–3 beyond that registry definition.
Manufacturer press (June 16, 2026) reports:
- 74.8% with ≥1-grade ATNLS improvement at month 1, written in the same sentence as (78.5/105). That fraction equals 74.76% but is not a whole-person count. Treat 74.8% as manufacturer-disclosed; prefer the S099 SSED table if the PDF is opened at the next label re-check.
- 66% (64/97) still ≥1-grade at six months.
- Labeled duration: six months with optimal treatment.
AbbVie also footnoted that neck treatment has not been studied in darker skin tone patients. That is a material Fitzpatrick gap, not a marketing afterthought. PIH and Tyndall risk in thin cervical skin still belong in the consultation for Fitzpatrick IV–VI patients even though this is an HA microdroplet, not a pigment laser.
These percents are not individual guarantees. Denominators (105 at month 1; 97 at month 6) are smaller than the 159 enrolled, which is expected in a modified evaluable set — the SSED, not the press parentheses, should settle the exact analysis set.
Anatomical Boundaries: What Skinvive Neck Treats vs What It Cannot Do
The most crucial clinical safeguard for patients is recognizing what microdroplet hyaluronic acid can and cannot treat in the complex anatomy of the neck.
| Presentation | What Skinvive can do | What actually treats that problem |
|---|---|---|
| Etched horizontal “necklace” creases | On-label S099 use: microdroplet HA for neck lines / neck appearance | Skinvive (PMA P110033/S099) |
| Vertical dynamic or resting platysma cords | None — HA does not relax muscle | Neuromodulator (see Botox for platysma bands) |
| Submental fat (“double chin”) | None — gel does not destroy fat | Deoxycholic acid, cryolipolysis, or liposuction |
| Severe redundant skin / musculofascial ptosis | None — microdroplets do not lift hanging folds | Energy tightening or surgical platysmaplasty / neck lift |
Press copy often says “tech neck.” The approval-order statement is reduce neck lines and improvement of neck appearance, not a named “tech neck” diagnosis.
1. Skinvive vs Platysma Muscle Bands
Vertical neck cords are caused by hyperkinetic contractions and structural dehiscence of the platysma muscle—a broad, superficial muscle sheet spanning the clavicle to the mandible. Injecting Skinvive into platysmal bands will not soften them, because hyaluronic acid has no neuromodulating or muscle-relaxing properties. Patients presenting with vertical banding require targeted neuromodulator therapy, as detailed in our guide on Botox for platysma bands.
2. Skinvive vs Submental Fat
Excess fullness beneath the chin represents pre-platysmal or sub-platysmal fat deposits. Microdroplet HA is a hydrating gel; injecting it into adipose tissue will only add superficial volume. Fat reduction requires targeted deoxycholic acid adipolysis, cryolipolysis, or surgical liposuction.
3. Skinvive vs Structural Laxity ("Turkey Neck")
When aging leads to significant elastosis, loss of deep retaining ligaments, and redundant skin sagging, superficial micro-injections cannot create mechanical lifting. Structural laxity requires deep acoustic micro-focused ultrasound (Ultherapy) or surgical neck lift (cervicoplasty). For a complete overview of horizontal line causes and device options, review our clinical guide on tech neck and horizontal neck lines treatment.
Injection Technique, Safety, and the Recovery Timeline
The anterior neck is thin, mobile, and close to named arteries. Skinvive is still a hyaluronic-acid implant: vascular occlusion is a named filler risk, and hyaluronidase is the reversal tool for HA. This page does not publish an emergency dose protocol.
Manufacturer materials describe administration with an ultrafine needle or cannula. Exact gauge, aliquot volume, and grid spacing belong in the DFU and the injector’s training — not as a universal 32-gauge / 0.01–0.05 mL recipe.
Expect small papules for a day or two while microdroplets hydrate. Bruising is common. Strenuous exercise, heat, and tight collars are typically deferred for a short window the clinician specifies. Pregnancy and nursing were trial exclusions; defer elective neck HA until that conversation is explicit.
Labeled duration is about six months with optimal treatment; retreatment is expected if the goal is to maintain the ATNLS change.
Syringe Math and Cost: What Does Skinvive for the Neck Cost?
Because Skinvive treatments are purely aesthetic, they are 100% out of pocket and not covered by insurance.
Neck syringe count is clinic practice, not a CMS schedule. Many quotes use one syringe for a limited band and two for multiple rings; that is a planning range, not the labeled volume. Cheek-era Skinvive often used two syringes (one per side) in S059 protocols.
CareCredit/ASQ360 April 2026 consumer-finance figures of about $723 per syringe (range about $522–$1,151) are a cheek-era national average, not a neck CPT rate. Multiply by the syringe count you are actually quoted. Budget retreatments around the six-month labeled window if you want to maintain the effect.
How to Choose: Skinvive vs Alternative Neck Modalities
Use this decision guide to determine whether Skinvive is the correct treatment for your specific neck concerns:
| Lean toward Skinvive if | Choose something else if |
|---|---|
| The main complaint is etched horizontal creases | Vertical cords appear when speaking or grimacing (neuromodulator) |
| You want an on-label HA option with a named US PMA study | A heavy double chin from submental fat (Kybella / liposuction) |
| You can accept a day or two of micro-papules | Moderate-to-severe hanging folds (energy tightening or surgery) |
| Your lines look like the trial population (ATNLS 2 or 3) | You want a polynucleotide product that is not US-approved (see Rejuran vs Skinvive) |
For readers evaluating international polynucleotide alternatives, compare this data with our detailed analysis of Rejuran vs Skinvive, or explore our guide on managing broader crepey skin treatments.
Questions to Ask Your Injector During Consultation
To ensure optimal safety and natural aesthetic outcomes, ask your board-certified dermatologist or plastic surgeon these targeted questions:
- "Are my neck concerns primarily dermal creases (appropriate for Skinvive) or do I have underlying platysmal banding or skin laxity?"
Why to ask: Confirms that your anatomical presentation matches Skinvive on-label indication rather than requiring neuromodulators or surgical lifting. - "How many syringes are you planning, and is this an intradermal/subdermal Skinvive placement rather than a deep bolus?"
Why to ask: Volume and plane matter more than a generic “neck filler” label. - "What should I expect regarding temporary micro-papules, and what is the plan if bruising occurs?"
Why to ask: Social downtime is usually a day or two of small blebs, not a surgical recovery. - "Has my skin phototype been studied for this neck indication, and how will you watch for PIH or Tyndall?"
Why to ask: Manufacturer materials state darker skin tones were not studied for neck treatment. - "How do you schedule maintenance if I want to keep the six-month labeled effect?"
Why to ask: Helps budget retreatment instead of treating one session as permanent.
How to Read S099 Versus Press Copy, and What Still Needs the SSED
S099 is a panel-track PMA supplement. FDA received it May 13, 2025 and decided June 11, 2026. That track is the pathway for a substantial labeling change such as a new indication. S097 (May 1, 2025) is a Special / immediate-track labeling change whose approval-order statement is postmarket-surveillance text in the patient labeling and DFU. Date proximity does not make S097 the neck indication.
The S059 cheek indication is intradermal smoothness. S099 adds intradermal and/or subdermal injection to reduce neck lines. Plane is therefore not automatically “the same as cheeks.” Exact aliquot size, needle versus cannula, and grid pattern belong in the DFU, not in a universal recipe on this page.
Candidacy rule from the US registry, not from marketing: NCT05316233 enrolled ATNLS grade 2 or 3. Grade 1 lines may not look like the trial photos. Extreme redundancy (grade 4 / “turkey neck”) is outside what microdroplet HA can lift.
Failure cases: if horizontal lines barely change and vertical bands dominate, more Skinvive is the wrong next syringe. If the quote is for a deep bolus “neck filler,” that is not the S099 microdroplet use. If phototype is Fitzpatrick IV–VI, the manufacturer footnote still applies: neck treatment was not studied in darker skin tone patients.
SSED still closed in this review. The next label check should open the S099 Summary of Safety and Effectiveness Data for the analysis set behind 74.8% (78.5/105), month-6 64/97, injection-plane tables, and Fitzpatrick distribution. Until that PDF is parsed, treat press percents as manufacturer-disclosed.
Cost math using the cheek-era average, not a neck CPT: one syringe at about $723 is about $723; two syringes about $1,446. Maintaining a six-month labeled effect is a second cycle in the same year if you re-treat on schedule. The $700–$1,600 table band is that syringe-count range, not insurance.
Combination with platysma neuromodulator is common clinic practice for mixed banding-plus-creases. It is not a labeled Skinvive-plus-toxin protocol on the S099 page retrieved here; sequence and spacing are the injector’s call.
Sources
- FDA PMA P110033/S099, SKINVIVE by JUVÉDERM, decision June 11, 2026 (panel track; NCT05316233): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P110033S099
- FDA PMA P110033/S059, Skinvive cheek smoothness, decision May 11, 2023: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P110033S059
- FDA PMA P110033/S097, Skinvive labeling/DFU postmarket-surveillance update, decision May 1, 2025: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P110033S097
- ClinicalTrials.gov NCT05316233, JUVÉDERM VOLITE XC for neck appearance (US; n=159; completed September 12, 2024): https://clinicaltrials.gov/study/NCT05316233
- ClinicalTrials.gov NCT05741034, JUVÉDERM VOLITE for transverse neck lines in Chinese adults (n=159; completed December 9, 2024; not the US PMA study): https://clinicaltrials.gov/study/NCT05741034
- AbbVie / Allergan Aesthetics, Skinvive neck approval press, June 16, 2026 (ATNLS percents; darker-skin-tone footnote): https://news.abbvie.com/2026-06-16-Allergan-Aesthetics-Receives-U-S-FDA-Approval-for-SKINVIVE-by-JUVEDERM-R-for-the-Improvement-of-Neck-Appearance
- ClinicalTrials.gov NCT03728309, Skinvive cheek smoothness pivotal (S059): https://clinicaltrials.gov/study/NCT03728309
- FDA-approved dermal fillers index: https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers
