What is Submental Fullness?
- Submental fullness due to submental fat – sometimes referred to as a double chin – is a common yet undertreated facial aesthetic condition. It can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look.
- Submental fullness can impact a broad range of adults and is not limited to people who are overweight. This condition can impact men or women of average weight and can be caused by aging, genetics and weight gain. It is often resistant to diet and exercise alone.
- According to a 2014 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are bothered by submental fullness – nearly as many as those bothered by lines and wrinkles around the eyes.
What is a Kybella (Deoxycholic acid) Injection?
- Kybella (deoxycholic acid) injection, also known as ATX-101, is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.
- Kybella is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of Kybella for treating subcutaneous fat outside the submental region has not been established and is not recommended.
How Does Kybella Work?
Kybella is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.
When injected into subcutaneous fat, Kybella destroys fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with Kybella is not expected. Due to its cytolytic activity, Kybella should not be injected into or near vulnerable anatomic structures.
Frequently Asked Questions
How is Kybella administered?
Kybella is administered by injections into the fat under the chin. Each in-office treatment session is typically 15-20 minutes. The physician customizes treatment with Kybella to the patient’s aesthetic goals for an improved chin profile.
What are the results of Kybella in clinical trials?
Kybella treatment resulted in high patient satisfaction. For example, 79% of patients treated with Kybella reported satisfaction with the appearance of their face and chin.
Many patients experienced visible results in two to four treatments. In addition, Kybella treatment resulted in high patient satisfaction.
In clinical studies, 28%, 43%, and 55% of Kybella-treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively.
Patients also reported improvement in the emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
Is Kybella safe?
Kybella has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with Kybella.
The production of Kybella is a highly controlled, quality-assured and validated, current Good Manufacturing Practices-compliant process to ensure patient safety. Kybella contains no human or animal-derived substances.
What are the side effects of Kybella™?
The safety profile of Kybella is well characterized. Side effects may include swelling, bruising, pain, numbness, redness or formation of small areas of firmness. Adverse events with Kybella infrequently resulted in discontinuation from the study (1.6% of participants). Care must be taken when injecting Kybella to avoid the risk of marginal mandibular nerve injury and dysphagia.