The filler is already approved to treat facial wrinkles and folds, like the smile lines that go from the nose to the corners of the mouth.

Many dermatologists and cosmetic surgeons are already skilled at using Restylane for lip augmentation because they had been using it as an off-label treatment for enhancing the lips prior to FDA approval.

According to a release from Medicis, maker of Restylane, a clinical study showed that the results last up to six months.

The study to evaluate the safety and effectiveness of Restylane for lip augmentation had 180 patients. Some received Restylane injections at the beginning and then were retreated at six months. Participants who did not get treatment at the start of the study received their first Restylane treatment at six months. Patients kept diaries for two weeks after treatment.

The study found that Restylane was well tolerated and effective for lip augmentation; side effects included pain, swelling, tenderness and bruising, and none were serious.

Patients in the study were clearly happy with the results, as 80 percent chose to get Restylane treatment again after six months.

Restylane was the first hyaluronic acid dermal filler approved in the U.S. It launched here in January 2004, and according to Medicis, it has been used in over 10 million treatments worldwide.

Hyaluronic acid is a substance naturally found in the body, and over time, Restylane is resorbed by the body as the treatment results wear off.

Results can be seen immediately after your Restylane treatment, and there is no downtime or recovery period after the procedure.

Learn more about lip augmentation.

“It’s a toxin-free alternative to treating unwanted lines and wrinkles, similar to what is being done with Botox and Dysport,” said study co-author Francis Palmer, director of facial plastic surgery at the University of Southern California School of Medicine in Los Angeles. From early clinical trials, this procedure appears to have the same clinical efficacy and safety comparable to the existing techniques, he added.

To perform the procedure, doctors use small needles that deliver cold to nerves running through the forehead, and the cold freezes the nerve, interrupting the nerve signal and relaxing the muscle that causes forehead lines. The technique does not permanently damage the nerve, Palmer said.

Researchers said they are still refining the technique but that the results last about the same amount of time as Botox, which works for about three to four months. However, unlike Botox, which takes a few days to kick in, the effects of the cryotechnology are seen immediately, according to the researchers.

The current study had 31 people, all of whom had fewer wrinkles after two to eight injections, and the level of discomfort was comparable to that from Botox or fillers, Palmer said.

If this new technique is eventually approved by the FDA, it would offer consumers an alternative to a neurotoxin injection for getting rid of forehead wrinkles. Statistics from both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery for 2010 showed that Botulinum Toxin Type A, which includes Botox and Dysport, was the number one non-surgical cosmetic procedure.

The company plans to seek FDA approval, but it may seek approval in Europe first.

Dr. Joel Schlessinger, a cosmetic surgeon, presented his findings at the American Society for Dermatologic Surgery 2010 Annual Meeting. His results were of a subset analysis of a phase 3 clinical trial designed to evaluate the effectiveness of Dysport.

An analysis of the Dysport group, which had 1160 participants, found that 19.7 percent of the patients responded to Dysport on day one, and that three days was the median response time to the Dysport treatment. Furthermore, Dr. Schlessinger said that Dysport appears to take effect slightly faster than Botox, by about two days.

Dr. Schlessinger explained, “There are many different neurotoxins out there, and they have different types of effects on the injected individual, depending on the physical and molecular makeup of the neurotoxin.”

Based on his findings, he points out that the quicker onset of Dysport “can be very helpful for a person who … has a social function coming up.”

Dr. Elliot Weiss from the Laser and Skin Surgery Center of New York in New York City, said the “study … validates what clinicians have observed clinically with the use of [Dysport] with regard to its early onset of action in many patients.”

Skin Speaks patients can view the comparable dosage and pricing charts for Botox and Dysport to get a better idea of pricing differences between the two.

Statistics compiled by the American Society for Aesthetic Plastic Surgery (ASAPS) show that for those in the 51-64 age range:

• The number of facelifts dropped from over 75,000 in 2008 to just under 55,000 in 2009
• The number of Botox procedures increased from 672,840 in 2008 to 734,751 in 2009

“If you are a woman who has to come back to work full-time or a man who isn’t going to be able to retire any time soon, you’ve got to look like you can compete,” says Wendy Lewis, a New York–based plastic surgery and skin care consultant. “And if you are working in a field like media where everyone is really young, you don’t just want to look good for your age, you want to look good, period.”

Overall the number of facelifts in the U.S. dropped 29 percent from 2008 and eyelid surgeries dropped 23 percent during the same time frame, according to ASAPS. Meanwhile, Botox and Dysport injections increased 3.8 percent from 2008 to 2009.

Less invasive procedures have several benefits for those in the job market: they require less recovery time and are generally less expensive compared to cosmetic surgical procedures.

Lewis does point out that minimally-invasive treatments can be overdone. “There is a point at which you are going to have a better result and spend less money if you just have a facelift,” she says. In addition, there are some problems, like sagging jowls, that can only be fixed by surgery.

Skin Speaks Spa MD offers a wide array of cosmetic non-surgical procedures, including Fraxel, Thermage, IPL (intense pulsed light), and Juvederm.

The market for botulinum toxin-A drugs, which currently includes  Botox and Dysport in the U.S., is estimated to grow to $543 million by 2017, and the aesthetic laser and light therapy markets for skin resurfacing, hair removal, and laser lipolysis are expected to be the fastest growing cosmetic procedure markets.

The report was done by iData Research, which specializes in medical device and pharmaceutical market research. Dr. Kamran Zamanian, CEO of iData, commented, “Allergan has had a monopoly on botulinum toxin A drugs since 2002 [with Botox], but now faces competition from Dysport by Medicis as well as other new competitors expected to enter the market. Allergan and Medicis have been fierce rivals, as their Juvederm and Restylane facial dermal fillers compete in the lucrative dermal filler market.”

The report also speculated that competition will intensify with the expected entry into the market of another botulinum toxin—PurTox by Mentor. According to Mentor, PurTox is in Phase III clinical trials in the U.S.

The use of botulinum toxins is also expected to increase due to a growing number of therapeutic treatments that go beyond filling wrinkles; for example, the FDA is currently evaluating Botox as a treatment for severe migraines.

At present, the U.S. market for injectables is valued at almost $860 million, according to the report, which is titled “Markets for Cosmetic Surgery, Facial Aesthetics and Medical Laser Devices 2011.” The three-report series includes data, analyses and competitor profiles for botulinum toxins, dermal fillers, breast augmentation implants, liposuction aspirators, laser/light devices, and microdermabrasion.

The challenge allows patients to save $75 when they try Dysport. If they “love it,” they receive $75 off their next Dysport treatment; if they don’t, patients receive a $75 rebate off another botulinum toxin type A product, such as Botox.

Over 91.2 percent of 22,416 patients who took the challenge from March 1 through May 9, 2010, made “Love It,” according to Medicis, the maker of Dysport. Only 2.6 percent of all registered patients have made a selection to “Leave It” since the program began.

When the challenge started, Jonah Shacknai, the chief executive of Medicis, said,“We are so confident that we are literally willing to bet our money that patients will love their Dysport treatment.”

Approved by the FDA in April 2009 to treat frown lines between the eyebrows, Dysport works much like Botox and is Botox’s first comparable competitor in the U.S. cosmetic market.  Dysport works by a process called neuromuscular blocking, which relaxes small muscles in the face and forehead that cause wrinkles to form.

In the release on passing the 100,000 registrant milestone, Shacknai said:

“We are pleased to announce this tremendous support by both physicians and patients for the Dysport Challenge. Medicis made a bold statement of confidence in the brand by offering patients the opportunity to try Dysport and save up to $150 total.”

Open to patients 18 and older, complete Dysport Challenge details are available at www.DysportUSA.com. Advancements in Dermatology and Skin Speaks Spa M.D. offers Dysport to patients in the Twin Cities area.

Newsweek surveyed 202 corporate hiring managers and found that 56 percent of them said qualified but unattractive candidates are likely to have a harder time getting a job. More than half recommended spending as much time and money on “making sure they look attractive” as on perfecting a résumé.

When the hiring managers were asked to rate nine character attributes in order of importance for job candidates, looks came in third, after experience and confidence—and before where an applicant went to school.

The report also includes an interactive feature called “The Beauty Breakdown,” which estimates what a lifetime of cosmetic maintenance will cost a “modern diva.” Gathering data from a number of sources—including the American Society of Aesthetic Plastic Surgeons and Allure magazine—it looks at beauty costs from the tween years through 50 plus for American women, coming up with a lifetime total of $449,127.

For those in their 30s and 40s that included treatments like microdermabrasion, Botox, lip plumping, and laser varicose vein treatments, in addition to hair care, waxing, and tanning. For women over 50, chemical peels and deep line wrinkle fillers were added to the regimen.

For the lifetime total, the amount spent on the face was estimated at just over $314,000, more than treatments on hair, the body, and hands and feet combined.

In today’s economy, spending money on these treatments may not be “frivolous,” the magazine notes.

“Economists have long recognized what’s been dubbed the ‘beauty premium’—the idea that pretty people, whatever their aspirations, tend to do better in, well, almost everything. Handsome men earn, on average, 5 percent more than their less-attractive counterparts (good-looking women earn 4 percent more),” the report says.

Dr. Carney’s Skin Speaks Spa M.D., with five locations in the Twin Cities area of Minnesota, offers a range of treatments to help you look your best, including Botox, chemical peels, and wrinkle fillers. (image via Newsweek.com)

Late last year Johnson & Johnson announced that it was discontinuing its collagen filler Evolence, and in January Allergan announced it would be discontinuing its collagen fillers at the end of the year. Allergan halted production of the products in 2009, but manufactured enough inventory to meet estimated market demand through the end of 2010, according to Kelly Lao, manager of corporate communications.

Patients who have received treatment with Evolence will continue to receive support regarding medical inquiries or reporting of adverse reactions.

As for Allergan’s collagen fillers, which includes CosmoPlast, CosmoDerm and bovine products Zyderm and Zyplast, Lao explains that “the discontinuation of the sale of our collagen products … is in response to declined market interest … since the introduction of hyaluronic acid dermal fillers like Juvéderm have become more popular.”

Seth L. Matarasso, M.D., clinical professor of dermatology at the  University of California School of Medicine, San Francisco, agrees with Lao’s assessment. “There is an overwhelming popularity of the new kid on the block: the hyaluronic acids. They have been embraced universally, and suddenly collagens aren’t as popular,” he says.

Hyaluronic acid products have several advantages, including:

• Longer-lasting results
• Appear to give a better fill
• Some contain lidocaine for less painful injections

Future improvements will allow hyaluronic acids to provide more volume and contour-changing ability and the ability to fill deeper lines, reports Dermatology Times.

Advancements in Dermatology and Skin Speaks Spa M.D. offer the following hyaluronic acids fillers: Juvéderm, Restylane, Radiesse, and Sculptra.

The full story is available online: “Dermatologists prepare for departure of collagen from U.S. market.”

Three 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.”

233 patients were treated randomly with Cosmoplast or Sculptra Aesthetic at 3-week intervals.  Injections were performed to reduce the appearance of the nasolabial folds – the lines that travel from the nose to the corner of the mouth. Post treatment visits were conducted at 3 weeks, 3 months, 6 months, 9 months and 13 months after the final injection.

Highlights of the study:

• During post-operative evaluations, Sculptra scored much higher on the wrinkle assessment scale.
• When the patients treated with Sculptra were followed an additional 12 months, they exhibited results lasting over two years.
• Results had a very natural appearance. “[Sculptra] works gradually to replace lost collagen due to aging, resulting in a more natural-looking appearance” said Dr. Gary Monheit of the University of Alabama Medical Center.
• Side effects were mild or moderate in intensity and overall, they occurred more frequently in the collagen group.

Read more about this study on the official press release from CNN.