Nashville-based Gold Skin Care and its Tennessee Clinical Research Center have been involved in a clinical trial for a new formulation that earlier this year received FDA approval. The product is a version of the dermal filler JUVÉDERM^®, and patients are heartily endorsing the innovation, said board-certified dermatologist Michael Gold, MD.

 

JUVÉDERM XC is the latest advancement in hyaluronic acid dermal fillers, and this one contains a pain killer that makes the injections less painful. The XC formulation boasts 0.3 percent preservative-free lidocaine, which numbs the treatment area within seconds. Gold said patients “feel the anesthetic effect on the second injection.” In other words, patients feel the pain of the first injection, but then don’t feel the second and subsequent shots. “It’s remarkable how fast it actually works. It doesn’t make 100 percent sense that it would work that fast, but it does. That’s one of the huge advantages of JUVÉDERM with lidocaine compared with JUVÉDERM alone.”

 

Gold Skin Care was one of four study sites around the country. Gold called the trial literally “a blind study,” and then explained: “We weren’t blinded, but the patients were blinded – meaning that they actually wore blindfolds. This was as blinded as you can get.”

 

The blindfolded patients randomly received the lidocaine-laced JUVÉDERM on one side of their face and regular JUVÉDERM on the other side. “The patients were asked to evaluate the pain during the injection, and then the blindfolds came off,” Gold said. Investigators asked the patients to rate the difference in pain after 15 minutes, 30 minutes, an hour and then the next day. Researchers also touched base with the participants two weeks later. According to Allergan Inc., the maker of JUVÉDERM, all the patients in the trial were treated for moderate to severe nasolabial folds (the parentheses from the nose to the chin). In the study, 93 percent of patients reported less pain when treated with the new JUVÉDERM formulation. “It certainly helps the patients with the injection process, so it was a really good study,” Gold said.

 

He noted that some people are allergic to lidocaine, so dermatologists who use JUVÉDERM must tweak clinical processes to ensure that patients are queried about lidocaine allergies.

 

Lidocaine has been used to relieve pain from other injections by dermatologists, Gold said, and he cited shingles treatment as an example. Post-shingles, dermatologist may inject steroids directly into the lesions, and adding lidocaine to the mix has been proven to be a painkiller.

 

Gold said he welcomes JUVÉDERM XC to the market because some dermatologists had already been adding liquid lidocaine from a bottle into dermal filler syringes. Yet, there was no assurance that some of the product’s properties weren’t lost. The XC compound adds powdered lidocaine to the filler, and the properties remain stable.