What is submental fullness?
- Submental fullness, sometimes referred to as “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, including both women and men, and can be caused by aging, genetics and weight gain.
- 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.
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 causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with KYBELLA is not expected.
- To avoid potential tissue damage, KYBELLA should not be injected into or in close proximity (1-1.5 cm) to the marginal mandibular nerve, salivary glands, lymph nodes and muscles.
How is KYBELLA administered?
- Treatment with KYBELLA is customized by the physician to the patient’s aesthetic goals for an improved chin profile.
- KYBELLA is administered by injections into the fat under the chin via 0.2 mL injections spaced 1cm apart using a 30G (or smaller) 0.5-inch needle.
- Each in-office treatment session is typically 15-20 minutes.
- In clinical trials, many patients experienced visible results in two to four treatment sessions spaced at least one month apart. Up to 6 treatments may be administered – 59% of subjects received 6 treatments.
What are the side effects with KYBELLA?
- 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.
- KYBELLA is manufactured through a highly-controlled, FDA-regulated process and approved facility to ensure patient safety.
- The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.
- Marginal mandibular nerve (MMN) injury occurred in 4% and dysphagia occurred in 2% of subjects. To avoid potential tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to the MMN, salivary glands, lymph nodes and muscles.