Newswise — If you're one of the millions of people who are searching for the perfect solution to reverse the aging process, you may be about to get an array of new treatment options to choose from. Thanks to the demand for longer-lasting treatments for aging skin with little downtime, new soft tissue fillers that are approved by the U.S. Food and Drug Administration (FDA) " or close to receiving FDA approval " are making headlines as viable options for those who want to turn back the hands of time.
Speaking today at the American Academy of Dermatology's (AAD) Derm Update 2003, dermatologist Alastair Carruthers, MD, Clinical Professor, Division of Dermatology, University of British Columbia, Vancouver, British Columbia, compared the advantages of the latest soft tissue fillers currently available in the United States and those under review by the FDA.
Bio-Engineered Human Injectable CollagenWhile traditional bovine collagen has been used as a filler to plump up and fill fine lines on the face with much success by dermatologists for more than 20 years, its short-lived results and potential for allergic reactions limited its potential. Today, a new filler recently received FDA approval known as bio-engineered human injectable collagen, which consists of collagen derived from human cells. While heralded for correcting facial wrinkles, acne scarring and reshaping the lips, bio-engineered human injectable collagen does not pose the allergy risk of traditional bovine collagen and patients are not required to undergo a skin test prior to its use.
"While this new human-based collagen is an improvement over bovine collagen because it does not pose an allergy risk, the results still only last about two to five months and it is not as effective when used deeper in the skin as some of the other fillers currently being tested," explained Dr. Carruthers. Similar to traditional collagen, bio-engineered human injectable collagen is formulated with an anesthetic to prevent any discomfort by the patient.Hyaluronic Acid Gel Another new soft tissue filler that is being studied in the United States but has not yet been FDA approved is a non-animal form of hyaluronic acid gel. Hyaluronic acid is a naturally occurring component of the skin that is the framework or medium that cells live in. In gel form, hyaluronic acid binds to water and provides volume to easily fill in larger folds of skin around the mouth and cheeks. This highly purified, non-animal form of hyaluronic acid has already been approved for use as a filling agent in Canada, Europe and Australia. "The results I have observed in my patients who I have treated with hyaluronic acid in Canada have been quite remarkable," said Dr. Carruthers. "Compared to bovine collagen, hyaluronic acid gel is a superior filler that works better for improving nasolabial folds, or the deep lines visible from the nostrils to the corners of the mouth, that can be hard to treat. In addition, the results of hyaluronic acid last longer and it requires less volume to fill wrinkles and skin folds compared to collagen."
An added benefit of the non-animal form of hyaluronic acid is that it does not pose an allergy risk for patients and there is no risk of transmitting animal diseases by injection. Despite its numerous benefits, Dr. Carruthers cautioned that there is usually temporary inflammation that produces swelling and redness following injection with hyaluronic acid " especially with the lips " and injections can be painful.
Hydroxyapatite with a methylcellulose vehicleFor patients who want longer-lasting results than the collagen fillers but are not ready to consider a permanent solution, a new filler known as hydroxyapatite with a methylcellulose vehicle is currently FDA approved for other purposes and can be used off-label as an injectable filler. This new breed of synthetic compounds contains beads of calcium hydroxyapatite, which is a substance used to replace missing bone. Dr. Carruthers said, "There are some concerns that dermatologists have with the product that patients should be aware of. For instance, the duration of this filler has not been demonstrated yet and there is concern that the beads could clump together if it is not injected properly." Since hydroxyapatite is radio opaque, there is the possibility that the filler could interfere with future dental x-rays.Polymethylmethacrylate For patients looking for a more permanent solution to their lines and wrinkles, one of the new permanent injectables that is awaiting FDA approval in the United States is polymethylmethacrylate. Made from a mixture of micronized plastic spheres and bovine collagen, polymethylmethacrylate has been shown to work well for moderate to deep wrinkles and scars but is not recommended for lips. When polymethylmethacrylate is injected into the skin, the collagen works by holding the synthetic spheres in place until it dissipates after injection " leaving the spheres behind to prop up the wrinkles. The spheres, which are not absorbed by the body, act to stimulate the body's own production of collagen, which then forms around the spheres. "Since the results of polymethylmethacrylate are permanent, it's extremely important that patients consult a dermatologist or dermatologic surgeon skilled in the procedure once it is approved for use in the states," cautioned Dr. Carruthers. "While there is little inflammation upon injection of polymethylmethacrylate compared to some of the other fillers, there are some side effects such as the possible development of granulomas, or permanent bumps under the skin, and long-term lumpiness in the lips." Liquid Injectable Silicone Until it was banned by the FDA in 1992, silicone was used in the United States for many years with much success to treat wrinkles and acne scars as well as to enhance areas such as the lips, cheekbones and the chin. When used cosmetically, the safety and efficacy was compromised when silicone was diluted with foreign substances or when it was injected in large volumes in an area during one treatment session. Now, a new medical grade form of silicone known as liquid injectable silicone has been approved by the FDA for use in the eye to treat chronic retinal detachment and is being studied in the United States to determine its safety and efficacy as a permanent filler for aging skin. Liquid injectable silicone has shown promising results in clinical trials for correcting wrinkles, acne scars, enhancing the lips, cheekbones and chin, and for filling out hollowed cheeks in HIV/AIDS patients. One of the main benefits of silicone that distinguishes itself from other fillers is that the results are permanent. "When the new medical grade form of liquid injectable silicone is used by skilled dermatologists or dermatologic surgeons, side effects are minimal," stated Dr. Carruthers. "But patients need to be aware that there are concerns about the possibility of developing long-term granulomas from using silicone and that the results, whether you like them or not, are permanent."
Dr. Carruthers cautioned that whenever patients seek treatments that produce permanent results like silicone or polymethylmethacrylate, the skill and experience of the physician are critical to the success of the treatment."In Canada and in Europe, we have found that the results of these new fillers are very skill dependent," explained Dr. Carruthers. "The best advice I can give patients looking for a permanent solution to their cosmetic concerns is to do their homework and discuss their expectations with their doctor." Before considering treatment with a soft tissue filler, the American Academy of Dermatology recommends potential patients ask the following questions:1. Are the results permanent or temporary?2. What are the potential side effects?3. Is the filler approved by the FDA or is it being used off-label?4. How long has the physician used the filler? Ask how many patients the physician has treated and if before and after patient photos are available.
The American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of over 14,000 dermatologists worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; supporting and enhancing patient care for a lifetime of healthier skin. For more information, contact the AAD at 1-888-462-DERM or http://www.aad.org.
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