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.
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.
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:
United States (17.5% of total procedures)
Brazil (14.3%)
China (12.7%)
India (5.2%)
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.
“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.
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)
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.
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.
Dr. Anne Chapas, a dermatologist in New York City, explained to Meredith Vieira how she used Fraxel, Thermage, and Isolaz to help the patients with a variety of skin problems, including skin laxity, acne, and sun spots—all without going under the knife.
Jill, a 40-something with years of skin damage from the sun, received Fraxel restore treatment. Dr. Chapas explains that Fraxel gives energy that stimulates new skin cells to grow and gives a refreshed appearance to skin, making it look more youthful and healthy.
Of the treatment, Jill says, “I’m thrilled. It really got rid of so much of the sun damage that I could see. It just makes me feel like I have fresh, new skin.”
Dr. Chapas estimates that it usually takes 1 to 3 treatments to see results. After treatment, patients may have a few days of redness and a little dryness, according to the doctor.
Lisa, a new mom, received Thermage treatment on her stomach. She says she had a lot of extra flab in her mid section after her second child. Thermage tightened her belly and helps her fit better in her clothes.
Thermage can also be used to tighten the face. Lisa B. was suffering from skin discoloration, breakouts and blotches, and looseness. She first received Thermage treatment, which helped tighten her skin and build collagen, followed by Fraxel the next week to help even out her skin tone.
Thermage and Fraxel treatments are available at Dr. Stacy’s Bellevue, Washington office. She is the number one Thermage provider in the state of Washington and patients frequently travel from southwest and eastern Washington, Alaska, Idaho, and Oregon for Thermage treatment. Learn more about travel accomodations.
Everything from facials to laser treatments can help you look your best, but don’t forget to be proactive about taking care of yourself between procedures. One habit that may help fight the effects of aging over the long-term is flossing.
Dr. Eugene Antenucci explained to MSNBC for a recent article that you leave 40 percent of your teeth dirty with bacteria if you’re not flossing, which causes staining and yellowing between and around teeth.
Too much plaque can lead to gingivitis, the first stage of gum disease. Gum disease symptoms include red, swollen, or bleeding gums, receding gums, and the formation of deep pockets between teeth and gums, according to WebMD. If left untreated, gum disease can end with tooth loss due to destruction of the tissue that surrounds your teeth.
“You register an older look because you see more spaces, less and uneven gum tissue,” according to Antenucci, a spokesperson for the Academy of General Dentistry.
Eventually gum disease can cause the bones underneath to dissolve away, explains Dr. Donald Clem, a dentist in Fullerton, Calif. “In later stages of periodontal disease we would see disfigurement in terms of caving in of the lips and cheek and wrinkles around the lips and cheeks.”
A range of cosmetic services, from Botox to a chemical peel, can help your skin look its best—and so can habits that you do every day, such as flossing and wearing sunscreen.
While women make up the majority of cosmetic procedure patients, men see the benefits as well. Men received 13 percent of all cosmetic surgical procedures and 9 percent of all cosmetic minimally-invasive procedures performed last year in the United States, according to statistics from the American Society of Plastic Surgeons (ASPS).
Bill Neville, 52, recently shared his cosmetic surgery story with reporter Elise Morgan of WHNT NEWS 19 in Huntsville, Alabama. Neville, who has a four-year-old son, began to worry about looking old: “He’s [his son] going to start t-ball, swimming, and I don’t want to be out there with the rest of the dads and have them looking at me like, ‘Hey! Grandpa is out here to watch his grandson!’”
Neville changed his diet and exercise but decided to get plastic surgery as well. “Just rolling back the clock a bit on this turkey gobbler and possibly getting the skin off my eyelids would be great,” he said before he had surgery.
His procedures included a facelift, a neck lift, laser resurfacing of his skin, and injections to fill in wrinkles. “I was hoping not to look real “plasticky” and stretched, and I don’t think I do,” said Neville. “I think it looks real natural and everyone I’ve talked to thinks it looks great.”
ASPS statistics show that the top 5 minimally-invasive cosmetic procedures for men last year were:
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.
