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The U.S. Food and Drug Administration (FDA) has approved Radiesse, a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds.
Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. The product provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen. Further, Radiesse provides physicians a high level of control, predictability and finesse for facial applications.
FDA approval of Radiesse for treatment of facial wrinkles and folds was based on the results of a clinical trial supporting Radiesse’s safety and effectiveness. In this study, conducted at four medical centers in the United States, 117 patients with nasolabial folds were treated with Radiesse on one side of the face and a control agent (Cosmoplast, a human collagen product) on the other. Results based on the ratings of three blinded evaluators showed that six months after treatment, Radiesse was more effective than the control on every comparative efficacy outcome (p<0.0001).
Key clinical findings include:
· 82 percent of nasolabial folds treated with Radiesse showed improvement after six months. This was significantly higher than the control, which showed improvement in only 27 percent of treated folds (p<0.0001).
· After six months, the fold treated with Radiesse was more improved in 79 percent of patients compared to the control-treated fold. The folds treated with the control rated more improved in only 5 percent of patients.
· The nasolabial folds treated with Radiesse required approximately half as much volume (1.22cc) than the folds treated with the control (2.35cc).
· Both products were safe and well tolerated, with no serious adverse events reported. In the 117 patients treated, Radiesse had zero granulomas and the same low rate of nodules as the control.
The U.S. Food and Drug Administration has approved a new treatment for moderate-to-severe frown lines, medically called nasolabial folds.
BioForm Medical issued a statement describing its Radiesse as a longer-lasting alternative to existing wrinkle fillers. The company said its calcium-based microsphere technology not only fills in facial folds and depressions, but also stimulates the body to produce collagen, the fibrous protein that gives the face its structure and fullness.
The drug was also newly approved to improve the appearance of people with AIDS-causing HIV who have significant facial fat loss (lipoatrophy), the San Mateo, Calif.-based company said.
Radiesse was first FDA approved in 2002 for use in facial reconstructive surgery.
HealthDay News, December 28, 2006
When it comes to treating the aging face, patients have their pick of numerous laser therapies for successful skin rejuvenation. But finding an effective treatment for the delicate skin of the neck can often be a real pain in the neck. Now, a retrospective review presented in a recent issue of Lasers in Surgery and Medicine, the journal of the American Society for Laser Medicine and Surgery, finds that a skilled practitioner can successfully resurface an aging and photodamaged neck using the Carbon Dioxide (CO2) laser if a series of treatment parameters are strictly followed.
In her article entitled “Safe and Effective Carbon Dioxide Laser Skin Resurfacing of the Neck,” laser expert Suzanne D. Kilmer, MD, of the Laser & Skin Surgery Center of Northern California, Sacramento, CA, outlines three key components essential to effective laser resurfacing of the neck with the CO2 laser that she and her colleagues have used to safely treat more than 1,000 patients over the past 10 years.
“We have found that for the CO2 laser to work safely and effectively on the neck, 1) the skin has to be sufficiently hydrated with a pre-operative topical anesthesia; 2) the laser has to be administered at a low density with only a single pass; and 3) the treated epidermis must not be wiped following the procedure,” explains Dr. Kilmer. “These three ingredients, in a sense, make up the ‘recipe’ for how to safely use the CO2 laser for neck resurfacing. And like all recipes, every step must be followed and all the ingredients must be added properly for the end result to turn out right.”
In order to adequately hydrate the skin prior to the laser procedure, Dr. Kilmer recommends that patients wash their entire face and neck with hot water and then immediately apply a thick layer—like frosting on a cake—of the topical anesthesia EMLA. The area is then sealed using a plastic wrap, and this process is repeated 45 minutes before the procedure. Dr. Kilmer notes that proper hydration is critical, as it “plumps up” the skin and creates a protective buffer against the laser that also aids in absorbing the laser’s energy.
During a typical laser skin resurfacing of the face with the CO2 laser, the epidermis is completely removed. For neck resurfacing, the laser energy is lowered so the epidermis is not removed and stays intact. This low density coupled with a single pass of the laser creates less trauma and less wounding on the neck. Dr. Kilmer points out that while the face would normally be wiped to remove the epidermal debris following the procedure, it is important not to wipe the treated epidermis from the neck because it serves as a natural dressing that protects the skin and aids in the healing process.
“Most of our patients that undergo CO2 laser skin resurfacing on their face also get their neck done at the same time,” says Dr. Kilmer. “Performing both procedures helps to blend the results, eliminating the noticeable line of demarcation that usually occurs when the neck is left untreated.”
While non-ablative laser treatment for skin rejuvenation has gained in popularity during the past few years, Dr. Kilmer notes that the CO2 laser produces longer-lasting results than its non-invasive counterparts and only a single treatment session is needed instead of a series of treatment sessions.
“As with any procedure, patients need to be informed of the potential risks, how much downtime is involved, and the importance of post-operative care before undergoing CO2 laser resurfacing,” adds Dr. Kilmer. “But for any single resurfacing treatment, the CO2 laser delivers the most overall improvement—hands down.”
Patients with a personal or immediate family history of vitiligo are not considered candidates for this procedure, as laser resurfacing can trigger depigmentation of the treated area consistent with this condition.
Personal misuse of super-strength botulinum toxin caused a Florida osteopath, his girlfriend, and two of his patients to become paralyzed and hospitalized for months in 2004.
Details of the much-publicized incident—which ended in the practitioner being sentenced to three years in prison—are only now published in this week's issue of the Journal of the American Medical Association.
At the time of the incident, Bach McComb was an osteopathic physician who was continuing to practice in Oakland Park, Fla., after his license had been suspended. In the four cases described, McComb did not use a medical version of Allergan Inc.'s Botox.
Instead, he mistakenly gave himself and the three others four to six injections of a preparation of paralyzing botulinum toxin that was 2,800 times stronger than that typically used on patients, according to the authors of the JAMA article. This formulation was only intended for laboratory work.
The vial's labeling clearly marked the product as not being suitable for human use.
"The fact that clinical practitioners were using an unlicensed product was very disturbing," said Dr. Christopher R. Braden, a medical epidemiologist at the U.S. Centers for Disease Control and Prevention, and an author of the report. "It needed to be highlighted and the issue dealt with so that it does not recur."
"A 100-microgram vial of toxin taken from the same manufacturer's lot as the toxin administered to the case patients contained a toxin amount sufficient to kill approximately 14,286 adults if disseminated evenly," according to the JAMA report.
McComb, his two patients, Eric and Bonnie Kaplan, and McComb's girlfriend, Alma Hall, were each paralyzed by the time they were admitted to a hospital.
All of the patients eventually survived but were hospitalized for months and required assistance for basic functions such as breathing, speaking and walking. McComb was later sent to prison for three years.
The incident does not reflect on the safety of standard treatments of Botox, stressed Dr. John Canady, a professor of plastic surgery at the University of Iowa and vice president of the American Academy of Plastic Surgeons.
"This was clearly not Botox," Canady said. "More than 3 million people got Botox injections in 2005, which is the last year we have statistics on, and I don't believe any reaction such as this has been reported."
The real Botox is carefully packaged by its manufacturer, Allergan, Canady explained. "Botox comes in a vial that does not have an excessive dose, and it is reconstituted in the same vial," he said. "None of these safeguards were in place" in the Florida case, Canady added.
Basic precautions against such misuse are obvious, Canady said.
"It is important to go to a board-certified plastic surgeon," he said. "You should feel free to ask that person what his track record has been in the use of Botox. Probably the biggest take-home message is that it is important to do your homework before any medical procedure, and that includes Botox."
In addition, "It's absolutely fair to ask what material is being injected into you personally," Canady said. "I don't think it's too much to ask to see the container or the material."
And Braden cautioned consumers about bargain-hunting.
The last time he looked at the Internet, he saw advertisements for "Botox-like" medications. "I would be very suspect of those kinds of products," Braden said.
By Ed Edelson, HealthDay Reporter, November 21, 2006
Murad's Lighten and Brighten Eye Treatment was the top pick for “Best Dermatologist Brand” in the annual Shape of Beauty Awards, chosen by Shape magazine editors, beauty professionals and more than 6,000 readers. 800-336-8723
The Board of Laser Safety (BLS)/The National Council on Laser Excellence (NCLE) now offer a collaborative, unified Certified Medical Laser Safety Officer program (CMLSO) to promote overall acceptance of laser certifications. To contact the BLS, call 407-380-1553. For the NCLE, call 614-883-1739.
By Nicholas Daniello, MD
Estheticians must familiarize themselves with the most recent nonsurgical techniques in order to better advise and retain clients.
Botox injections can help facial wounds heal with less scarring, a small study finds.
"This is the first medication found to minimize scarring," senior author Dr. David Sherris, professor and chair of the department of otolaryngology at the University at Buffalo, said in a prepared statement.
His team published the study in the August issue of Mayo Clinic Proceedings.
The study included 31 patients who suffered wounds to the forehead or had surgery to remove skin cancers from the forehead, an area that's particularly susceptible to scarring. The patients received either an injection of Botox or saline within 24 hours after wound closure.
Photographs were taken at the time the patients received the injections and again six months later. The photographs were reviewed by two facial plastic surgeons who weren't involved in the study. They rated the patients' wound healing on a scale of zero to 10, with 10 representing the best result. The two surgeons' scores were averaged to reach a final score for each patient.
The median scores for wounds injected with Botox were 8.9, compared to 7.1 for wounds injected with saline.
"The result is of substantial interest in the field of scar treatment. When a wound occurs, especially on the face, people are always worried about the scar. We can now try to improve scars with these injections," Sherris said.
The study was funded by a clinical research grant from the Mayo Clinic.
HealthDay News, August 24, 2006
The California Senate has introduced Senate Bill 1423, which will restrict registered nurses, physician assistants and physicians who have esthetic practices from using laser and IPL systems. In addition, Massachusetts, Georgia and North Carolina are considering similar bills.
According to “Cosmeceuticals in the U.S.,” a new report from market research publisher Packaged Facts, a division of MarketResearch.com, American spa-goers have turned their attention from injectables to cosmeceutical treatments. Sales of products such as anti-wrinkle creams and home facial peel kits jumped 7% last year to more than $13.3 billion. Projections estimate that the cosmeceuticals market will surpass $17 billion in 2010, growing a total of 29.4% between 2005 and 2010.