The US FDA has expanded the arsenal of aesthetic dermatology treatments with another approved indication for a hyaluronic acid dermal filler and clearance for a device that removes “micro-cores” of skin to improve the appearance of facial wrinkles for use on other parts of the body.

Restylane Lyft with Lidocaine, a hyaluronic acid injectable, is now approved for “augmentation of the chin region to improve the chin profile in patients older than 21 years with mild-to-moderate chin retrusion,” the manufacturer Galderma announced in a November 5 press release. In addition, Ellacor, a dermal “micro-coring” nonsurgical device, has received 510(k) clearance from the FDA to expand use to treat sagging skin beyond the face to other areas of the body, according to a press release from the manufacturer Cytrellis.

Restylane Lyft has previously been approved for treating the midface, facial folds, and wrinkles, including nasolabial folds, and the backs of the hands, according to the company.

The approval for chin augmentation was based on unpublished clinical trial data showing improved chin projection from baseline at 3 months, when 99.1% of investigators and 94.4% of participants reported visible improvement, according to the release. At 12 months, 95.5% of investigators and 89.0% of participants reported sustained improvement, the press release said. 

No unexpected or serious adverse events related to the product were reported; the most common side effects were bruising, nodules, exfoliation, hemorrhage, edema, papules, and redness. Some participants also reported pain, tenderness, swelling, itching, and lumps or bumps. Rare serious side effects included delayed onset infections, superficial necrosis, and scarring at the injection site, according to the company. The product is contraindicated for individuals with allergy to lidocaine or with bleeding disorders and should not be used by pregnant or breastfeeding women.

Galderma is submitting additional regulatory applications outside of the US to expand the use of Restylane Lyft for chin augmentation, according to the company.

The Ellacor procedure removes “micro-cores” of skin using hollow needles with a diameter less than 0.5 mm to improve the appearance of wrinkles in the mid- and lower face without scarring, stimulating collagen and elastin production, according to Cytrellis. The expanded FDA clearance, announced by the company on November 6, allows the device to be used to treat skin laxity on the arms, knees, abdomen, or any other area of the body, in addition to the face. The device was cleared for use in treating moderate-to-severe wrinkles in the mid- and lower face in 2021. 

The procedure is contraindicated for individuals with open wounds, sores, or irritated skin in the treatment area and should not be used by women who are pregnant or breastfeeding or those with an allergy to stainless steel, according to the company.

Potential side effects associated with Ellacor include redness, swelling, bruising, burning, dryness, roughness, tightness or skin pulling, crusting, and pain or discomfort. Other potential side effects include tenderness, tingling, bleeding, numbness, skin peeling, or circular marks on skin, the company release said.

The Restylane research was funded by Galderma.