Skinvive: the FDA-approved skin booster for cheek smoothness, its trial results and risks

Skinvive by Juvederm is a hyaluronic acid gel with lidocaine, injected into the skin. The FDA approved it on 11 May 2023 to improve skin smoothness of the cheeks in adults over the age of 21.¹

Here is what the FDA's approval file says about the study behind it, the side effects and who it hasn't been tested in. It gives no dose. Whether to have it is for you and a clinician.

What it is

The gel is made of hyaluronic acid, cross-linked, with 0.3% lidocaine, a numbing agent, and it is for intradermal injection, meaning into the skin itself.¹ It is a device, not a drug, and the FDA's consumer update lists hyaluronic acid among the materials used in temporary fillers.²

What the FDA approved it for

The approval says one thing: improving skin smoothness of the cheeks in adults over 21.¹ The file states that safety and effectiveness for other areas of the body haven't been established in controlled studies.¹ Ask any provider who offers it elsewhere what the use is based on.

The pivotal study

The FDA's summary describes a randomized, controlled study in which 135 people were treated, with an untreated group for the first month. The main measure was a photo rating, the Allergan Cheek Smoothness Scale, which runs from 0 to 4. A person counted as a responder with at least a 1-point improvement in both cheeks.¹

At one month, 57.9% of the treatment group were responders, against 4.5% of the untreated group. Among treated people with data, 55.6% were still responders at six months. Repeat treatment was offered at six months.¹

This was the manufacturer's study, summarized by the FDA, and the responder rate is a rating on a scale. It isn't a measure of how any one person will look.

Side effects

In the study, injection site responses were mostly mild, and lasted 7 days or less. Examples are redness, pain, tenderness, firmness, swelling, lumps, bruising and itching.¹ Three people (1.5%) had lumps or bumps that went away 12 to 15 months after treatment.¹ Treatment-related adverse events were reported by 16.0% of people after the first treatment, most often a mass at the injection site. All were mild to moderate. One person had a moderate nodule and redness that began more than 90 days after treatment.¹

The file warns that late-onset events can occur with injectable gels. Reports from outside the US after approval include inflammatory reactions, inflammatory nodules, unsatisfactory results, loss of correction, allergic reactions, vascular occlusion and infection.¹

The file's warning is that the product must not be injected into blood vessels. Serious events reported with injectable gels in the face include vision impairment and blindness, stroke and skin necrosis.¹ The FDA's consumer update says the same for dermal fillers generally.²

Who it hasn't been tested in

The file says Skinvive must not be used by people with severe allergies with a history of anaphylaxis, or an allergy to the bacterial proteins it contains traces of, or to lidocaine.¹ Its safety hasn't been established in pregnancy, in breastfeeding or in people under 22, and hasn't been studied in people prone to keloid scars, hypertrophic scarring or pigmentation disorders. It should be used with caution in people on immunosuppressive therapy.¹

Medicines that prolong bleeding, such as aspirin, anti-inflammatory drugs and warfarin, may increase bruising. If a laser treatment or a chemical peel follows, or comes before the skin has healed, an inflammatory reaction is possible.¹ Tell your provider about your medicines and any planned procedures.

At the clinics we list

611 of the 7,475 med spas we list name Skinvive among their brands. Naming a brand doesn't tell you what a clinic uses or for which area, so ask.³

Which licensed professionals may inject depends on your state. See our guide to choosing a lip filler provider for the checks that apply to any filler.

Here is what to bring to a consultation.

Cost

We don't give prices on this page.

Common questions