In clinical trials for years as an injectable fat reduction treatment, ATX101 has finally received formal FDA approval. Now known as Kybella from Kythera Biopharmaceuticals, medical grade deoxycholic acid has been approved to treat double chins. Specifically it is intended to create an improvement in the appearance of moderate to severe submental fullness in adults.
Kybella is a proprietary formulation of a synthetic version of deoxycholic acid. Deoxycholic acid, also known as deoxycholate (and technically as 3?,12?-dihydroxy-5?-cholan-24-oic acid) is a bile acid that in the human body in naturally produced by the liver and stored in the gall bladder. It is secreted into the small intestine to help break down dietary fat. Sodium deoxycholate, the sodium salt of deoxycholic acid, is often used as a biological detergent to breakdown cells and cell membranes and has served as one of the agents that has been used in mesotherapy for years.
As a liquid formulation of deoxycholic acid, Kybella is an injection that causes the destruction of fat cells through cell membrane breakdown. Once broken down the fatty acids in the fat cells are released and subsequently absorbed, creating the external appearance of reduced fullness. Kybella is an injection series that requires multiple treatments for maximum submental fat reduction. The submental area is injected in a grid pattern with a small 30 gauge needle spaced about 1 cm apart. The injection sessions are spaced four to six weeks apart and can take up to four to six treatment sessions to see the full effect.
How safe and effective is Kybella for reducing double chins? In two clinical trials of over 1,000 patients (Kybella vs. a placebo), a significant percent of patients (up to 20%) who received Kybella had at least a two-grade improvement on a physician Submental Fat Rating Scale and a Patient-Reported Submental Fat Rating Scale. This compares to just 3% of the placebo patients. Nearly three-quarters of Kybella patients had at least a one-grade improvement. Additional testing showed that Kybella also had significant improvement as demonstrated by MRI scans of fat reduction and patient-rated appearance assessments.
While Kybella can help dissolve submental fat and is a non-surgical treatment, there are some short-term after effects. The most common and are expected is swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area. These occur because it works by creating an inflammatory reaction which is how it breaks down the fat cells. Most of these reactions resolve in about one week after the injection treatment.
Currently, Kybella is only FDA-approved for the treatment of double chins. (submental fat fullness) But it is only a question of time and further study that it will be applied to other small fat problems. (e.g., small abdominal fat collections, lipomas)
Dr. Barry Eppley
Indianapolis, Indiana