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Fraxel re:store Dual, a non-invasive laser resurfacing treatment, has been granted clearance by the FDA for the treatment of actinic keratosis (AK), also known as sun or precancerous spots.

The FDA clearance was given partly because of data from a six-month study of 21 patients with AK, each of whom underwent a series of two to four laser treatments, spaced two to four weeks apart. Results showed that the treatment yielded a mean 83.5 percent decrease in age spot lesions on the face and other areas of the body, including the arms, hands and chest. Improvements in skin texture and pigmentation were also reported.

“In our study, we found the Fraxel re:store Dual to be the most effective treatment of multiple facial AKs, as it is safe and requires minimal downtime while simultaneously improving other signs of photodamage,” said Dr. Roy G. Geronemus, director of the Laser and Skin Surgery Center of New York, in a news release. “While the 83.5 percent removal rate was comparable to other topical therapies and AK treatment options, Fraxel was overwhelmingly well-tolerated by all the patients and offers the added benefit of improving a patients’ overall skin quality, color and texture.”

Fraxel re:store Dual has a 1927 nm wavelength in addition to a 1550-nm deep-penetrating Erbium fiber laser. The 1927 nm wavelength is optimized for treatment of pigmentation and other superficial skin conditions, such as AK.

The FDA has also cleared Fraxel re:store for:

• Skin resurfacing
• Eye wrinkles
• Acne scars
• Surgical scars
• Skin discoloration and pigmented lesions, such as age spots and sun spots

Patients frequently travel to Dr. Stacy Cosmetic  in Bellevue, Washington, from across Washington, Alaska, Idaho and Oregon for Fraxel re:pair laser resurfacing treatment. Fraxel re:pair treatment has FDA clearances for wrinkles, irregular texture, sun and age spots and sun-induced redness.

SmartLipo is a type of liposuction that uses a laser to assist in the removal of unwanted body fat. This laser-assisted liposuction device removes fat and reshapes areas of the body with precision and less downtime than traditional surgical liposuction. 

With SmartLipo, the laser targets fat cells and dissolves the cells on contact; a gentle suction then removes the dissolved fat. It can be used on many areas of the body, including the abdomen, back, thighs, hips, knees, arms, neck, and chin. 

Skin tightening is another benefit that has been attributed to laser liposuction; fat removal alone can’t correct poor skin elasticity in older patients. But while makers of laser liposuction platforms have claimed that their systems can produce noticeable skin tightening after liposuction, most of the time they don’t cite clinical evidence to back up their claims. 

New Jersey plastic surgeon Dr. Barry DiBernardo recently published a study that evaluates the skin tightening effects of laser liposuction, comparing SmartLipo to traditional liposuction. He enrolled ten subjects who had both unwanted abdominal fat and a mild to moderate degree of loose skin. Each subject underwent liposuction or laser-assisted liposuction on a randomly selected side of the body. 

Patients were evaluated one month and three months post-operatively, and a noticeable difference was documented in skin shrinkage and tightening. “The mean skin shrinkage ratios were significantly higher on the laser-treated side than on the suction side,” Dr. DiBernardo said.

Dr. Stacy is nationally known for her ability to achieve results with SmartLipo, and patients often travel to her Bellevue, Washington practice from Alaska, Oregon, Idaho, and from across Washington for their treatment. View SmartLipo before and after photos of Dr. Stacy’s patients to see the results.

Allergan, the maker of Botox, has agreed to pay $600 million in fines for marketing their product for uses for which it hasn’t been FDA approved.

Documents released by the Justice Department outlined claims that Allergan had built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, muscle spasticity and cerebral palsy in children, according to the New York Times. Doctors are allowed to prescribe drugs in off-label ways that they deem medically appropriate, but it’s illegal for a drug maker to promote these off-label uses.

Allergan has denied the criminal and civil accusations, except for the one misbranding charge, said Caroline Van Hove, an Allergan spokeswoman.

While Botox is best known as a wrinkle fighter, it has been approved to treat a range of  muscle and gland disorders, including uncontrolled blinking and excessive underarm sweating, and its uses continue to grow.  The New York Times reports, ”This year, the agency again expanded the use of Botox, permitting injections for increased muscle stiffness in the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.” Allergan is also studying Botox as a treatment for overactive bladders, in addition to owning patents on several other potential treatments.

In an e-mail to a reporter,  Ms. Van Hove wrote, “I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm, and we adamantly deny any implication that this occurred.”

She also stressed that Allergan has spent hundreds of millions of dollars in research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she added.

Maybe you remember the Solta Medical illumiNATION tour that came through Bellevue last fall, or perhaps you even saw their heavily branded silver Airstream Trailer driving down the road, fully equipped with Fraxel and Thermage treatment stations inside.

According to a recent press release, the company was awarded the Silver Anvil Award from the Public Relations Society of America in the category of “Best Special Events and Observances.”

Why Solta Was Given the Award – via PR Newsire

The illumiNATION tour introduced the two latest advancements in the aesthetic industry – the Thermage CPT and Fraxel re:store Dual – to physicians and consumers in over 45 cities in the U.S. and Europe in Fall 2009. The tour was comprised of an on-line and on-the-road communications program. It produced unprecedented results, including more than 200 million media impressions, thousands of visitors and increased sales for the Thermage and Fraxel systems throughout the effort. Due to the success of the program, a Canadian tour followed in the spring and stopped in 8 cities across Canada, generating the same great results Solta experienced in the first tour.

Botulinum toxin injections (Botox, Dysport) were the top plastic surgery procedure in the world last year, according to statistics recently released by the International Society of Aesthetic Plastic Surgery (ISAPS).

Billed as the first reliable international plastic surgery data ever surveyed, the data showed that botulinum toxin injections were performed 2,860,238 times last year, 32.7% of all non-surgical procedures.

It was followed by hyaluronic acid injections as the number two non-surgical procedure, which made up 20.1% of all non-surgical procedures. The rest of the top 5 non-surgical procedures were laser hair removal (13.1%); autologous fat injections (5.9%); and IPL laser treatment (4.4%).

Chemical peel, microdermabrasion, laser skin resurfacing, sclerotherapy, and laser treatment of leg veins rounded out the top 10.

The number of non-surgical procedures topped the number of surgical procedures, “reflecting both advances in cosmetic surgery innovation and the desirability of less expensive treatments,” according to ISAPS.

Liposuction was the top plastic surgery procedure, representing almost 19 percent of all surgical procedures. It was followed by breast augmentation (17%); eyelid lift (13.5%); rhinoplasty (9.4%); and tummy tuck (7.3%).

The top procedures do vary among countries. “It is not always liposuction and breast augmentation that are No. 1,” says Foad Nahai, MD, ISAPS President and a plastic surgeon in Atlanta. For instance, injectables are not yet as popular in other countries as they are in the U.S., he says.

The United States had more than 3 million plastic surgery procedures (surgical and non-surgical) performed in 2009, making it the country with the most procedures.

The top 5 countries, by total number of procedures, were:

1. United States (17.5% of total procedures)
2. Brazil (14.3%)
3. China (12.7%)
4. India (5.2%)
5. Mexico (4.8%)

“It is no surprise to me that the United States has the largest number of aesthetic procedures, and same with Brazil,” says Dr. Nahai. “But countries like China and India with emerging economies are generating a lot wealth and as that wealth is passed around, people are choosing to their spend discretionary income on aesthetic procedures.”

For more information on the statistics, visit the ISAPS website.

A disturbing trend at cosmetic and dermatology centers is being reported at msnbc.com: “cosmetic” criminals who get non-surgical cosmetic treatments and then leave without paying or write a bad check.

The Latest “Beauty Bandit”

The latest case was a woman who received over $3,000 worth of Botox and dermal fillers in a Fort Lauderdale dermatology center and then disappeared after telling staff she had to run to an ATM.

Dubbed the “Beauty Bandit,” the suspect was arrested recently, but others have been reported, including cases in Newport Beach, Calif.; Port St. Lucie, Fla.; Tampa, Fla.; Brisbane, Australia and Kenton, England.

“From talking to our doctors, this is a problem that’s occurring from coast to coast,” says Jeff Karzen, spokesman for the American Academy of Cosmetic Surgery.

The Upswing in Cosmetic Crimes

According to msnbc.com, doctors are pointing to the bad economy as one factor in the increase in these crimes, nicknamed “pricks-and-runs.” Another reason some cite is the perceived “necessity” of cosmetic procedures.

Botox is no longer considered a luxury says Dr. Jon Grazer, a Newport Beach plastic surgeon who was hit by a Botox bandit last year. “It’s something people have to have, and if they can’t afford it because of the economy, I think it’s going to push them to get it by whatever means they can.”

“We’ve had it happen three times,” says Las Vegas cosmetic surgeon Dr. Samir Pancholi. “The first time, it was a woman in her 50s who came in and got treatment, then said, ‘My purse is in the car, I’ll go grab it and be right back.’ Then she was gone.”

Avoiding “Pricks-and-Runs”

To avoid falling victim to these “beauty bandits” again, many offices affected by these crimes are changing their payment rules, such as  requiring all new patients to pay prior to receiving treatment.

XEOMIN is the latest botulinum toxin type A product to be approved by the FDA, after Botox and  Dysport. A product of Merz Pharmaceuticals, XEOMIN has been approved for therapeutic treatment of adults with cervical dystonia or blepharospasm.

The National Institute of Neurological Disorders and Stroke defines dystonias as movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Focal dystonia, which includes cervical dystonia (twisting of the neck and sometimes the shoulders) and blepharospasm (excessive eyelid spasm), affects about 295 people out of one million in the U.S., according to a study conducted in Rochester, Minnesota.

The approval of XEOMIN comes after two U.S. clinical trials. The Journal of Neurological Sciences cited a study on the efficacy and safety of XEOMIN, in which XEOMIN showed “non-inferiority” to Botox when used to treat cervical dystonia. XEOMIN “is a safe and effective treatment for CD [cervical dystonia]” it concluded.

Xeomin, according to Merz, is the only botulinum toxin that doesn’t require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage and help ensure product integrity at the time of injection.

Merz had announced earlier this year that it was acquiring BioForm Medical, a leader in the U.S. and European dermal filler markets with its Radiesse dermal filler. Merz will be renamed “Merz Aesthetics” after the acquisiton is complete.

Revance Therapeutics, a privately held specialty biopharmaceutical company in California, is exploring a Botox product that could be applied to the skin in cream form—no needles necessary, reports WCBS-TV in New York City.

Revance says that it will be two years before clinical trials of the product, called RT001, are complete. Then the FDA will decide whether to approve the drug, which is being tested for use on crow’s feet, according to WCBS-TV.

Some doctors worry about the safety of such a product. In an interview with WCBS-TV, Dr. David Colbert, a New York City dermatologist, says he worries that a Botox lotion product would be so popular that black market versions would be sold online without oversight and that the potential muscle paralyzing effects could be dangerous.

“I think it’s a brilliant idea, but I’m more concerned about the welfare of people who would use it irresponsibly,” he says.

Patients in the early trials tended to see a moderate reduction in wrinkles around their eyes after using the product for a month. The product is being tested on crow’s feet because the skin around the eyes is thin and susceptible to bruising when Botox is injected.

Dr. Richard Glogau, a clinical professor of dermatology at the University of California, San Francisco, who is a primary investigator for the study, said after early trials that Revance needed to rework the formulation so the drug would stay where it was applied and not spread to other parts of the body.

Dr. Anthony Youn, a plastic surgeon in Michigan, had some interesting thoughts on the product’s potential. He writes on his website: “I think a huge application of this topical botulinum toxin is in sweat reduction. Could you imagine an antiperspirant stick with this product that lasts several months with each application and leaves no residue? I’d buy it!”

To watch the WCBS-TV segment, go to http://wcbstv.com/video and search for “Botox cream.” (Pictured: before & after use of RT001 for 28 days; image via WCBS-TV)

Actress Claire Danes is the newest celebrity spokesperson for Latisse, and her before and after photos are now posted on latisse.com.

She follows in Brooke Shields’s footsteps as a spokesperson for Allergan’s eyelash product, which is the first and only prescription treatment approved by the FDA to grow lashes longer, fuller and darker. Since its approval by the FDA in December 2008, about 1.5 million kits of Latisse have been sold.

The before and after gallery follows Danes’s 16-week treatment on Latisse, with photos at week 0, 4, 8, 12, and 16 at front, angled, and profile views that clearly show her lash growth. The website notes that none of the photos were retouched.

Danes recently commented that she became a “Latisse girl” because she was curious about the product. “The more I learned about Latisse, the more impressed I was. I’ve never used a product that actually affected real physical change,” she added.

Latisse was discovered by accident when Allergan was developing a clinical trial for a glaucoma treatment called Lumigan in 2001. Patients reported a side-effect—significantly longer eyelashes—and Allergan began investigating other uses.

During research of Latisse, doctors reported on average:

• 25 percent increase in eyelash length
• 106 percent increase in eyelash fullness
• 18 percent darkening of the eyelashes

Latisse is applied to the base of the lashes, and patients usually start to see results in a few weeks. The effects of Latisse are not permanent, so regular use is necessary. Eyelashes will return to normal after the patient stops applying Latisse.

Contact Dr. Stacy Cosmetic in Bellevue, Washington for more info and special pricing for Latisse. (Before and after photo via latisse.com)

The U.K.’s drug regulator became the first in the world to approve Botox as a tool for preventing chronic migraine headaches, Allergan announced last week. Best known as a wrinkle treatment, it can now be used on migraine patients in the U.K. who have headaches at least 15 days a month, including migraines on 8 days.

Allergan’s clinical trial involved 1,384 adults who had a history of migraines and experienced 15 or more headache days of which at least 50 percent were migraine or probable migraine during the 28-day period.  At the end of the baseline period, patients were randomized to receive either Botox injections or placebo.

By week 24 following treatment, patients who received Botox averaged 8.2 fewer migraine days, which was significantly greater than the change from baseline observed in placebo treated patients of 6.2 days.

Lee Tomkins, director of Migraine Action, stressed it was not a “cure” but it offered hope for those who suffer the most frequent migraines. Migraine symptoms may include severe headache; visual disturbances such as spots or flashing lights; sensitivity to light, noise, or smells; and nausea and vomiting.

“We have been following these studies really closely and the evidence is really pretty solid. These people spend half their lives in pain. Even if they get half the attacks, it can really improve their quality of life,” said Tomkins.

In the United States, the Food and Drug Administration is likely to decide this month whether the product can be sold for migraines, Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, said in May. In the U.S., in addition to treating wrinkles Botox can be used to treat eye muscle spasms and muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity.

Botox was the number one minimally-invasive cosmetic procedure in 2009 according to the American Society of Plastic Surgeons’ most recent statistics, which showed that the procedure was performed 4.8 million times in the U.S. last year for cosmetic purposes. Dr. Stacy performs the procedure in her Bellevue, Washington office.