Posts Tagged ‘hyaluronic acid’

The Latest Injectable Advancements

Monday, June 21st, 2010

Juvederm logoThe July 2010 issue of Cosmetic Surgery Times reports on some of the latest news in the U.S. injectables market, including FDA-approved lidocaine hyaluronic acid fillers and fillers that may soon reach the American market.

Restylane logoThree injectables received FDA approval in February 2010 for lidocaine versions in the U.S.: Juvederm XC, Restylane-L, and Perlane-L. Lidocaine is a local anesthetic that is injected directly into the body and decreases pain by temporarily numbing the injection area, according to WebMD.

Dr. Michael H. Gold, a clinical assistant professor of dermatology at Vanderbilt University School of Medicine and School of Nursing, says that the products performed similarly to their lidocaine-free predecessors in terms of efficacy and safety.  “The incorporation of lidocaine has surely provided a higher comfort level for patients [in the clinical trials],” he adds.

Based on his clinical experience, Dr. Gold reports that when a patient undergoes an injection that includes even a small percentage of lidocaine that most patients say they barely feel the second injection. “To me that is the home run of lidocaine in these fillers,” he says.

In other injectable news, a filler that will soon reach the American market is Belotero Balance for nasolabial folds correction, which Dr. Gold says is awaiting FDA approval. Belotero Balance was first introduced in Germany in 2005.

Learn more about Juvederm and Restylane in the Twin Cities.

Read more about the latest in injectables online at Modern Medicine: “Fillers with lidocaine among latest injectable advancements.”

New “No Pain” Juvederm XC Now FDA Approved

Friday, February 5th, 2010

At Skin Speaks, we are planning to carry the new Juvederm XC immediately! You can look forward to trying it at your next Juvederm appointment.

As with the original Juvederm, the product lasts up to 1 year from initial treatment. The addition of 0.3% lidocaine numbs the treatment area within seconds, potentially decreasing the need for additional anesthetic.

“Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient’s discomfort during the injection. Before the introduction of Juvederm XC, it often took up to 30 minutes for an anesthetic block to take effect.” said Charles Boyd, MD, Boyd Cosmetic Surgical Institute and clinical investigator in a company news release. “[W]ith the new formulation, patients can receive the same smooth results as demonstrated with Juvederm but enjoy a more comfortable injection experience.”

FDA approval was based on data from a multicenter, double-blind, randomized clinical trial in which 72 patients received 1 of the 2 formulations in each nasolabial fold. Results showed that 93% of patients reported less procedural pain when treated with the lidocaine-containing dermal filler compared with the original version.

The safety profile was similar for both products, with temporary injection-site erythema, inflammation, pain/tenderness, firmness, lumps/bumps, and bruising most commonly reported. Most adverse events were mild to moderate in nature and of short duration (≤7 days).

With FDA approval, the lidocaine-containing dermal filler is available by prescription nationwide. As with the original formulation, it should only be administered by a trained medical professional.