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-Rolling Meadows, IL. The U.S. Food and Drug Administration's (FDA) clearance of a new class of
soft tissue fillers may give hyaluronic acid-based injectables the potential to become the next "hot shot" for
erasing wrinkles. On Friday, a panel of medical experts convened by the FDA will review the clinical data for
two synthetic versions of hyaluronic acid gel that will be marketed under the brand names of RestylaneTM and
Hylaform.TM The panel will then vote in favor of or against recommending marketing approval. While the FDA does not
have to take the recommendation of the panel, the agency usually does.
Used safely and effectively worldwide for years, hyaluronic acid is a naturally occurring element in human
connective tissue and is an important component of youthful skin because it binds to water and provides volume.
In gel form, dermatologic surgeons inject it into the skin to soften smile lines around the mouth, fill the wrinkles
that begin at the edge of the nose and extend down to the corners of the mouth (medically termed nasolabial folds),
enhance lips and smooth scarred skin.
While botulinum toxin type A (BotoXTM) is now considered the gold standard for treating dynamic frown lines and creases
on the forehead and around the eyes, the new dermal fillers target wrinkles in the lower half of the face. Skin
surgery experts explain that botox relaxes the overactive facial muscles that cause expression lines, whereas
hyaluronic acid gels and other fillers like collagen shore up lines and replace tissue volume that is lost with aging.
Dr. Rhoda S. Narins, president-elect of the American Society for Dermatologic Surgery (ASDS), is excited about the
choice of dermal fillers now available or soon to be on the U.S. market. "It's all about volume, longevity and
patient safety," she explains when discussing the ideal soft tissue fillers. "Hyaluronic acid and other new agents
coming online will offer fabulous results and more options for filling the syringe. In fact, we are already seeing
a significant increase in the use of wrinkle fillers overall," added Dr. Narins of New York City.
According to statistics from the American Society for Dermatologic Surgery (ASDS), there was
a 36% rise in soft tissue filler procedures performed in 2003 compared to 2001. The medical group also reported
450,000 Botox procedures performed in 2003 - a dramatic 47% increase since 2001.
Two clinical studies recently published in Dermatological Surgery, the peer-reviewed scientific Journal of the
ASDS, compare the use of hyaluronic acid gel with other fillers and Botox, alone and in combination, with
remarkable results.
A multicenter comparative study led by Dr. Narins and published in June 2003 comprised the clinical protocol and
data submitted for the FDA approval of the non-animal stabilized form of hyaluronic acid (KASHA). In this study,
134 patients with prominent nasolabial fold were treated with KASHA (Restylane) and bovine collagen (ZyplastTM) on
opposite sides of the face. Treatments were repeated at 2-week intervals, as required, to achieve optimal cosmetic
results, defined as baseline. Outcomes were evaluated at 2, 4, and 6 months after baseline.
Results revealed that both Restylane and Zyplast were equally effective in producing aesthetic correction but
that Restylane provided a more durable aesthetic improvement and was well tolerated. According to Dr. Narins,
"Bovine collagen (Zyplast) provides shorter term correction and can cause hypersensitivity reactions. The benefits of
KASHA are that it binds to water in the body, keeping the skin plump and elastic; it seldom causes allergic
reactions, allowing same-day treatment; and the results last anywhere from six month to a year."
The second study, by Vancouver-based dermatologic surgeon and ASDS spokesperson Dr. Alastair Carruthers, compared
the efficacy of Botox with KASHA (Restylane) versus the efficacy of KASHA (Restylane) alone. Published in August
2003, the study revealed that in certain cases of dynamic and/or resting forehead furrowing, Botox alone may not
be sufficient. "We conducted a comparison study on the efficacy of Botox combined with injectable non-animal
stabilized hyaluronic acid with the efficacy of hyaluronic acid alone. The Botox plus hyaluronic acid group showed
a better, longer-lasting response," Dr. Carruthers concluded.
Studies like these and other research investigations by leading dermatologic surgeons provide further evidence of
the significant clinical contributions made by skincare specialists. It also underscores the importance of choosing
a qualified dermatologic surgeon for cosmetic skin rejuvenation. "Patient safety and clinical efficacy are our
chief concerns," says ASDS president Dr. Ronald Moy, Los Angeles, CA. "However, there's a tendency for doctors
with no cosmetic training and even non-physicians to jump on the bandwagon. However, patients should be aware
that aesthetic results with soft tissue fillers are skill dependent and dermatologic surgeons have the training,
technical know-how and artistic finesse to ensure consistent, outstanding results."
The American Society for Dermatologic Surgery was founded in 1970 to promote excellence in the field of
medically-necessary and cosmetic dermatologic surgery and to foster the highest standards of patient care.
For more information on wrinkle fillers and referrals to board-certified specialists in specific geographic areas,
please contact the ASDS Consumer Hotline, 1-800-441-ASDS (2737), during weekday business hours or log on
to http://www.asds.net/. |
