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The Food and Drug Administration approved the intradermal microdroplet injection, a hydrating gel product designed to smooth out patients’ skin in those over 21 of all Fitzpatrick skin types.
Allergan Aesthetics, an AbbVie company, announced that the US Food and Drug Administration (FDA) approved of a product known as ‘Skinvive’ (by Juvederm) a hyaluronic acid intradermal microdroplet injection designed to smooth out the skin and last 6 months without recurring treatments.1
The new intradermal injection is unique as it has been approved for each and every Fitzpatrick Skin Type (I-VI), from the lightest to the darkest, for patients 21 and older and it is designed to flow easily into patients’ skin.
The company’s statement also noted that the injectable gel contains a small amount of local anesthetic—specifically lidocaine—and its effects on patients’ skin are meant to last 6 months using optimal treatment.
The new specialized, hydrating microdroplet injection is created to leave a glow on patients’ skin that lasts 6 months and to be minimally invasive, according to company officials, with little downtime if any and no recurring treatments necessary.
“Skin quality is among the top concerns my patients express when seeking aesthetic treatments. It's an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance," Macrene Alexiades, MD, PhD, dermatologist and lead investigator on the new product, said in a statement.
Alexiades also added that enhancement of skin hydration is important for the skin’s quality overall, noting that the new hydrating gel is designed for this purpose.
A randomized, multicenter, evaluator-blinded, controlled pivotal clinical study had been conducted prior to the approval, and 58% and 56% of participants saw an improvement of at least 1 point on the Allergan Cheek Smoothness Scale (ACSS) by 1 month and then 6 months, respectively.
The study’s investigators also noted that regarding patient satisfaction rates, 63% of participants were reported to be satisfied with the radiance of their skin at 6 months, compared to 11% prior to the treatment. Additionally, 72% were found to be satisfied with the skin’s hydration, compared to 24% before treatment, and 69% of patients were satisfied with how refreshed their skin looked compared to 16% prior.
Notably, the research team also found that at 6 months, 83% of participants reported being satisfied with the health of their skin compared to 38% before the treatment.
The team also found that most participants reported experiencing side effects, including redness, swelling, bruising, lumps/bumps, tenderness, firmness, discoloration, pain, and itching at the sites of the treatment’s injection.2
Most of the reported effects were said to have been mild or moderate, and some of the study’s participants experienced severe side effects.
Needle abrasion and papule were also reported by the trial investigators, and although it was rare, some of the participants reported side effects that continued over 30 days. That being said, most were found to have gone away on their own within the span of 30 days.