Kybella Clinical Trials

What are Kybella Clinical Trials?

Kybella is the brand name of synthesized sodium deoxycholic acid, a type of bile acid found in the bile of mammals. Sold by Allergan Aesthetics, it is used as an injectable to reduce the excess submental fat found beneath the chin for cosmetic appearance. The FDA approved Kybella in 2015.

Why Is Kybella Being Studied In Clinical Trials?

A 2021 consumer survey conducted by the American Society for Dermatological Surgery found that 70% of participants were bothered by the fat under their chin, with many willing to get it fixed if they had access to a safe cosmetic procedure. This makes injectables like Kybella a popular and safer alternative to invasive surgeries like liposuction and fat excision, procedures with a myriad of complications and risks.

As the demand for non-surgical cosmetic procedures increases, researchers continue to study compounds and non-invasive therapies that can be used instead. Given Kybella's positive and permanent results, clinical trials are working to find other areas of the body where Kybella can be used to dissolve fat.

While Kybella's fat-reducing ability appears to be permanent, there is still not enough data available to establish its long-term effects on health.

How Does Kybella Treatment Work?

Treatment with Kybella is done in two to six sessions, separated by four to six weeks. In each session, 10 mL of Kybella is injected in 0.2 mL doses under the chin in 20 to 50 locations within a defined area about one centimeter apart. A mild burning sensation and numbness follow the injections, which eventually subsides within the week.

The active ingredient in Kybella is deoxycholic acid, a naturally occurring substance in the digestive system. This compound emulsifies fats so that they can be absorbed in the intestine. Similarly, when injected into the submental fat of the chin, Kybella destroys the fat cell's membrane, effectively dissolving the fat deposit in that area and resulting in a more defined chin and jawline.

What Are Some of the Breakthrough Clinical Trials Involving Kybella?

2016: Known as the Refine 1 ATX-101 trial, this placebo-controlled clinical trial took 256 subjects aged 19 to 65 and gave them six sessions of Kybella. 70% of subjects saw a reduction of fat in this area compared to a placebo group. In this trial, 85% of the subjects were women, and 87% were Caucasian.

2020: This clinical trial, sponsored by Juva Skin & Laser Center and Allergan, tested the safety and effectiveness of Kybella to reduce the fat tissue in the area below the underarm, commonly known as "bra strap fat." Females between 18 and 65 were injected with 10 mL of Kybella over six sessions, and initial findings showed a decrease in fat cells in that area.

Who Are The Key Opinion Leaders On Kybella Clinical Trial Research?

The American Academy of Cosmetic Surgery (AACS)

The American Academy of Cosmetic Surgery (AACS) is the country's leading board of cosmetic surgery education. Since its founding in 1985, the AACS has worked with specialists from fields ranging from dermatology to general surgery, providing training and professional development. The AACS also facilitates research to advance cosmetic surgery and aesthetic medicine.