Crown Aesthetics announced that the U.S. Food and Drug Administration (FDA) has cleared SkinPen Precision for the treatment of wrinkles on the neck. The administration's decision came following a recent single-center clinical study, which demonstrated clinical improvement of dermal lines on the neck and high patient satisfaction at one month and three months post-treatment. From this study, it was found that:
- 94% of patients noticed an improvement in how their wrinkles looked in their treated area one month post-procedure
- 88% of patients were satisfied with their SkinPen Precision treatment one-month post-procedure
The clinical trial also showed that the SkinPen Precision device is safe for use with a depth of up to 2.5 mm on the neck. This allows patients to achieve more meaningful results with no adverse effects. SkinPen is the first and only FDA-cleared microneedling device with indications for both face and neck. "This new and expanded indication will completely change the way the industry has been treating wrinkles on the neck," says Joe Proctor, president of Crown Aesthetics. "With SkinPen's microneedling technology, we continue to set a higher standard in patient care as the world's first FDA-cleared microneedling device. SkinPen has been clinically proven to safely and effectively treat facial acne scars in patients ages 22 and up and we are excited to now add the expanded indication to treat wrinkles on the neck. We, at Crown, are fully committed to our practice partners across the globe and their desire to provide superior clinical outcomes to their patients. Through our continuous innovation and constant pursuit of clinical excellence, we continue to drive value and further meet the needs and expectations of our physician partners and their patients."