Thinking about how to get rid of that double chin? You are not alone.
Bayer Healthcare along with California-based Kythera Biopharmaceuticals have begun the third round of clinical trials to test a drug called ATX-101 that targets fat cells deposited under the chin. This area is called SMF or submental fat.
Currently, liposuction is the procedure used for removal of fatty deposits under the chin but the procedure can have some adverse effects.
A few years ago a drug called Lipodissolve was promoted as a “lunchtime lipo” alternative. It contained two chemicals, phosphatidylcholine (PC) and deoxycholate (DC).
However neither of these drugs were approved by the FDA for fat elimination.
ATX-101 is just sodium deoxycholate (DC in solution) in synthetic form, which acts like human bile and which causes dietary fat to degrade.
Deoxycholate is actually a common ingredient in soap. It behaves in the body the same way as it does in the wash, where it dissolves grease and oil from your clothes, said abcNews.com.
The most recent trial involved 732 patients from Europe. Kythera is in the process of carrying out another phase III trial in the United States and Canada with findings expected to be available later this year.
The results of two placebo-controlled studies already performed were very positive. Bayer Healthcare reported, “Significant improvements in clinician-reported measurements of SMF, supported by objective caliper measurements of SMF thickness.”
During the trials, the drug was administered monthly for four months and follow-up was performed for an additional three months. Adverse reactions included injection site pain, swelling, bruising and numbness according to Bayer, as reported to Medpagetoday.com.
Dr. Barry Eppley, a plastic/cosmetic surgeon in Indiana, believes the FDA will approve it in the next few years.
Concerns about the use of this new drug were expressed to abcNews.com by Dr. Darrick Antell, a plastic surgeon at Roosevelt Hospital in New York and a spokesman for the American Society of Plastic Surgeons.
"There's no doubt in my mind that if it's approved for the small area [under the chin], then people will start using for large areas and I have no doubt that there will invariably be adverse effects.”
And then there is that obvious question: Where does the dissolved fat go?
Dr. Carolyn Jacob, director of Chicago Cosmetic Surgery and Dermatology, questioned whether small bits of fatty tissue could potentially clog arteries or cause a stroke. She also expressed concern about what could happen if the drug leaked into surrounding tissue and possibly cause damage.
If ATX-101 becomes approved, then the risk that some will be tempted to try it on larger areas it is not intended for such as the abdomen and buttocks does exist.
Both doctors Antell and Jacobs voiced the need for practitioners and patients to be very cautious should ATX-101 become available for use.
Sources:
Studies Back Drug to Trim Double Chin By John Gever. Medpagetoday.com. Retrieved Feb. 7, 2013.
http://www.medpagetoday.com/Dermatology/GeneralDermatology/37162?utm_con...
Docs Question Bayer's Injection for Dissolving Double Chin. ABC News. Retrieved Feb. 7, 2013.
http://abcnews.go.com/Health/WellnessNews/bayer-tests-fat-loss-injection...
Fat Injection Drug Shows Promise For Neck Fat Reduction. Explore Plastic Surgery. Retrieved Feb. 7, 2013.
http://www.exploreplasticsurgery.com/2012/03/30/fat-injection-drug-shows...
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith