DALLAS, April 8, 2021 / PRNewswire / – Crown aesthetics, a division of Crown Laboratories, Inc. and a US leader in Microneedling Technology, today announced that the U.S. Food and Drug Administration (FDA) has approved SkinPen® Precision for the treatment of neck wrinkles.
The administration’s decision came after a recent single-center clinical study, which demonstrated clinical improvement of the dermal lines in the neck and high patient satisfaction at 1 and 3 months after treatment1. From this study, it was found that:
- 94% of patients noticed an improvement in the appearance of their wrinkles in the treated area one month after the procedure
- 88% of patients were satisfied with the SkinPen Precision treatment one month after the procedure
The clinical trial also showed that the SkinPen Precision device is safe for use with a depth of up to 2.5 mm at the neck. This allows patients to achieve more significant results without adverse effects1. SkinPen is the first and only microneedle device approved by the FDA with indications for face and neck.
“This new and expanded indication will completely change the way the industry has been treating neck wrinkles”, 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-approved microneedle device. SkinPen has been clinically proven to treat facial acne scars safely and effectively in patients from the age of 22 and we look forward to now add the expanded indication to treat neck wrinkles. We at Crown are fully committed to our practice partners worldwide and their desire to provide superior clinical results for their patients. Through our continuous innovation and constant search for clinical excellence, we continue to add value and meet even more the needs and expectations of our partner doctors and their patients. ”
Crown Aesthetics has already started the process of publishing data for the study of this indication and plans to present at global meetings of aesthetic dermatology at the end of the year.
Crown, a global, private and fully integrated skin care company, is committed to developing and providing a diverse portfolio of aesthetic, beauty and therapeutic skin products that improve the quality of life for its customers. An innovative company focused on skin science for life, Crown’s relentless pursuit of providing therapeutic excellence and better patient outcomes is the reason why it has become a leader in dermatology and aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing list of private companies for seven years and has expanded its distribution to more than 38 countries. For more information about Crown or its products, visit www.crownlaboratories.com.
About Crown Aesthetics
Crown Aesthetics, the leading medical aesthetics company, is dedicated to helping leading aesthetic practices worldwide to expand their business. We do this by delivering dramatic results in rejuvenation and restoration. Our non-invasive innovations – SkinPen®, the first microneedle device approved by the FDA; the Skinfuse® post-microneedling protocol; and the ProGen platelet-rich plasma (PRP) systemTM Advantage – act as “gateway” products that attract new consumers to the practices. Based in Dallas, Texas, Crown Aesthetics sets industry standards for effectiveness, safety and innovation. As a result, our customers consistently offer the best aesthetic care on the market. For more information please visit www.crownaesthetics.com.
1 510 (k) Trade / device name: SkinPen K202243 precision system
Indications / intended use: The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of neck wrinkles for Fitzpatrick II – IV skin types and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 or over.
SOURCE Bellus Medical, a division of Crown Laboratories