KYBELLA™ Scientific Evidence
When a novel cosmetic treatment like KYBELLA™ achieves FDA approval and becomes available to the public, it is often greeted with a lot of enthusiasm and high hopes. While patients are very welcoming of non-surgical treatments that can potentially substitute for surgical procedures, they have also learned to be cautious about how high their expectations should be. The cosmetic industry has a habit of over-promising and under-delivering when it comes to some non-surgical outcomes! Given this reality, I wanted to present some of the scientific evidence that supports the use of KYBELLA™. My hope is that this information will help in your research and allow you to make a more informed decision about whether KYBELLA™ is for you.
There are several studies that provide the scientific foundation for the use of KYBELLA™ to reduce fat under the chin. I’ll review a few of them here.
Ascher, et al Study:
A study of 360 men and women from various countries with average to severe fat located underneath the chin were randomly treated with either a placebo or KYBELLA™ injections. This randomization was performed by an automated voice response system. Four treatments of either the placebo or KYBELLA™ were given 28 days apart. A grid was used to map out exactly where each of the injections would take place. Topical lidocaine or lidocaine injections were used to increase comfort. The results revealed that 62.3% reported an improvement after KYBELLA™ treatments (2 mg/cm2). Only 34.5% reported a difference after receiving the placebo treatment. All elements of this clinical trial were properly controlled. From this study, researchers concluded that KYBELLA™ may be a solution for patients seeking improvement in their submental area.
Rzany, et al Study:
The purpose of the Rzany study was to determine how effective and safe KYBELLA™ (ATX 101) is in treating patients with submental fat. 363 patients ranging in age from 18-65 years old with average to above average submental fat were randomly selected to receive either a placebo injection or an injection containing deoxycholic acid (ATX 101). Male and female patients received up to four treatments about a month apart, along with a three-month follow-up. Patients were instructed to try to maintain their normal weight. Results revealed that 65.3% of patients given ATX 101(2 mg/cm2) were pleased with their results compared to 23% of those given the placebo. They also reported feeling less negative emotions surrounding their face/neck. Even though side effects such as swelling, bruising, and numbness occurred more often in those given KYBELLA™ (ATX 101) compared with the placebo, the treatment was well-tolerated.
Induction of fat cell necrosis in human fat tissue after treatment with phosphatidylcholine and deoxycholate:
The objective of this study was to determine if the injection of substances containing phosphatidylcholine and deoxycholate caused necrosis (the death of cells) or apoptosis (program cell death). Ten participants with familial multiple lipomatosis were selected, ranging in age from 23-36. After the substances were injected into biopsied tissue, these tissue samples were assessed under a microscope. The results revealed necrosis in all fatty tissue, but not apoptosis. Researchers made clear that further studies in which different doses are administered at different time frames should be conducted. This result potentially supports the use of KYBELLA™ to induce necrosis of submental fat.
The three studies above provide some of the scientific evidence that supports the use of KYBELLA™ for fat under the chin. Like any other cosmetic treatment, what is most important is that the patient is given balanced and objective advice about the best treatment approach for their specific goal. I would be very happy to meet with you and discuss what your best options are for submental fat treatment. Please contact Sistine Plastic Surgery today for more information, or to schedule a consultation.