Questions about Kybella Clinical Trials Facts
What is Kybella?
The generic name of Kybella is deoxycholic acid. It is produced by Kythera Biopharmaceuticals, Inc. The approval date by FDA through clinical trials is on 29 April 2015
Kybella is a synthetic form of deoxycholic acid. The acid occurs naturally in our body and helps breakdown and absorb dietary fat.
Kybella is used to specifically improve the appearance and shape of double chin. Severe fat below the chin, also called submental fat, has always been a problem for many patients. However, it is not known if Kybella is safe and effective for use outside of the area below the chin.
What Kybella brings to you
Treatment of double chin has always involved surgery. Hardly any exercise could target submental fat effectively. Even dieting will not help in reducing double chins.
Being administered by injections, Kybella makes the reduction of double chin less threatening and painful. And since deoxycholic acid works natural to destroy fat cells, it is relatively safe.
This is in contrast to liposuction, which is a surgical procedure that requires anaesthesia, incisions and downtime.
How many injections of Kybella is required for a treatment?
In general, patients will need a series of 12-20 injections per visit. A total of 3 visits might be required, with each visit spaced a month apart. The treatment only takes 15 minutes.
According to Kythera, results can be seen in 2 to 4 treatments.
What were the clinical test results of Kybella?
The baseline demographics out of 1022 patients consist of 156 males and 866 females. 87% are White, 8% Black or African American and 2% Asian. The rest comprise of a mixture of other races.
Patients were randomly assigned to receive either Kybella Jabs or placebo injections for a total of 6 treatments. Nobody knew what were given to each patient.
The trials were based on the measurement results on double chin.
It is reported that the efficacy of ATX-101 (Kybella) was demonstrated in improvement in the appearance of the modeate to severe convexity or fullness associated with double chin in adults when injected for up to 6 treatment sessions.
You can view the original FDA report here.
What are the possible side effects of Kybella?
Some of the side effects include headaches, nausea and difficulty in swallowing. At the local site of injections, there was swelling, numbness, hematoma fomation and skin tightness.
Every plastic surgery procedure carries its risks and rewards. Kybella has proven to be very effective in double chin reduction. And since it is non surgical, it is worth considering. After all, Kybella through clinical trials is FDA approved and it is safe to use.
Check out more writeup on Kybella here.