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FDA Clears SkinPen Precision Microneedling System for Neck Wrinkles

Sponsored by: Crown Aesthetics. Neck wrinkles might have gone under the radar before the pandemic, but that changed when COVID-19 fears forced people to replace in-person meetings with virtual connections. Thanks to the “Zoom boom” and “tech neck,” the neck took center stage. Investigators safely treated patients' necks with the SkinPen microneedling and demonstrated clinical improvement of dermal lines on the neck.

Sponsored by: Crown Aesthetics

Neck wrinkles might have gone under the radar before the pandemic, but that changed when COVID-19 fears forced people to replace in-person meetings with virtual connections. Thanks to the “Zoom boom” and “tech neck,” the neck took center stage.

Crown Aesthetics (Dallas, Texas) is leading the charge to correct this troubling area, announcing in April 2021 that the FDA cleared its SkinPen Precision microneedling system to treat neck wrinkles.

“SkinPen was the first induction therapy with needling to obtain an FDA clearance. I think that demonstrates the company’s commitment to the science,” said Michael H. Gold, MD, of Gold Skin Care Center (Nashville, Tenn.).“Anytime you go through the FDA process, you are investing not only in the technology, but you are looking at the safety of it, the satisfaction from it, and the results that you get. I like that commitment.”

The FDA’s most recent clearance for the microneedling technology comes on the heels of a single-center study of 35 subjects (including patients with darker skin types) ages 35 to 65 years. Patients were treated with the SkinPen four times, on days 1, 30, 60, and 90, with follow-up visits at one month and three months after the final treatment.

Transdermal delivery devices, microneedling, skin tightening, RFMichael H. Gold, MD DermatologistGold Skin Care CenterNashville, TN

Investigators safely treated patients' necks with the SkinPen microneedling device at a depth of up to 2.5 mm and demonstrated clinical improvement of dermal lines on the neck and high patient satisfaction at one and three months post-treatment. At one month, 94% of patients noticed an improvement in the appearance of the wrinkles, and 88% were satisfied with the treatment. More than 80% of participants said they would recommend the device to improve neck wrinkles.

There were no adverse events in the study. The SkinPen Precision system is safe to use as a treatment for neck wrinkles in patients with Fitzpatrick skin types II - IV, according to Crown Aesthetics.

What to Expect

Microneedling treatment of the neck generally takes about 10 to 15 minutes, according to Dr. Gold.

In general, from three to six treatments are recommended to treat neck wrinkles or acne scars, which was the original indication cleared by the FDA, according to company literature.

“Depending on how aggressive the treatment, pinpoint bleeding might occur, but that goes away pretty quickly,” Dr. Gold noted.“You can use topical numbing, and with that, patients are comfortable. They are going to be red for a day or two, and there is some swelling associated with the procedure. But downtime should be nothing significant. That is the joy of microneedling, there is not a lot of downtime.”

More than 2 million patients worldwide have been treated with the SkinPen Precision microneedling device. And most SkinPen Precision procedures have a return on investment (ROI) of about 450%, according to Crown Aesthetics literature.

Crown Aesthetics will be publishing the study data on neck wrinkles and presenting it at global aesthetic dermatology meetings in 2021.

 

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