RADIESSE More Effective Than Restylane As Reported In a 60-Patient Clinical Trial
January 14 2008 - 6:30AM
PR Newswire (US)
- CLINICAL TRIAL RESULTS PUBLISHED IN THE JOURNAL OF DERMATOLOGIC
SURGERY - SAN MATEO, Calif., Jan. 14 /PRNewswire-FirstCall/ --
BioForm Medical, Inc. (NASDAQ:BFRM) today announced the publication
of a post-marketing multi- center, randomized, blinded comparative
study of nasolabial fold treatments reporting that RADIESSE(R)
dermal filler was found to be significantly more effective than
Restylane(R), the leading dermal filler on the market worldwide.
The results of this study will be published in the February 2008
Issue of the Journal of Dermatologic Surgery, a peer-reviewed
publication of the American Society of Dermatologic Surgery. The
full published study is available for download at
http://delivery.sheridan.com/index.php?ID=blk/BLK_132142_CP This
study is the first published direct comparison study of RADIESSE
dermal filler against Restylane. The study concluded that 1)
patients preferred RADIESSE dermal filler two to one over
Restylane, 2) patients reported higher satisfaction and indicated
they were substantially more likely to return for future treatments
with RADIESSE filler than with Restylane, 3) at all time points
through 12 months (9 months after the second injection), RADIESSE
filler was found to provide greater improvement than Restylane in
nasolabial fold ratings assessed by a blinded evaluator at each
site, and 4) both products were safe and had similar adverse events
related to local injection site events typical of dermal fillers.
Approximately 30% less RADIESSE volume than Restylane volume was
required to reach full correction in this split-face trial
comparative trial. In conclusion, the study authors noted that "In
this head-to-head study with NASHA (Restylane), CaHA (RADIESSE) is
the first product to demonstrate greater durability and comparable
safety. We believe that CaHA (RADIESSE) will play a significant
role in the practice of many aesthetic medicine practitioners."
"This study demonstrated that it takes less RADIESSE filler to
achieve full or optimal correction, and the effect provides more
improvement of the fold with results that last longer. We believe
that this combination of benefits is what patients and physicians
want in a dermal filler, and is why physicians are rapidly adopting
RADIESSE in their practices," commented Steven Basta, Chief
Executive Officer of BioForm Medical. "Along with the previously
reported study results comparing RADIESSE filler with other leading
fillers, this study further demonstrates that RADIESSE filler is
the best value and provides the most satisfying outcomes among the
leading fillers." RADIESSE vs. Restylane Clinical Trial A
60-patient blinded, comparative split-face study was conducted at
two clinical sites in Europe to assess the aesthetic improvement in
treating nasolabial folds with RADIESSE dermal filler as compared
to Restylane, the leading hyaluronic acid filler on the market. The
results of this prospective, randomized, controlled clinical study,
led by Marion Moers-Carpi, MD, Hautok, Munich, Germany, and Jaime
Ope Tufet, MD, Barcelona, Spain, demonstrated that at all time
points, RADIESSE filler demonstrated longer lasting results,
significantly higher patient and physician preference, and greater
improvement as compared to Restylane filler. The study was designed
to measure the results achieved by RADIESSE filler and Restylane
filler on a split-face comparative basis. Each patient was
evaluated at baseline and after the completion of two treatments at
baseline and at three months in order to achieve full correction.
The paper published in the Journal of Dermatologic Surgery reports
on results achieved through a 12-month period (9 months following
the second treatment). The results of the study demonstrated that
upon evaluation as measured by the Global Aesthetic Improvement
Score (GAIS), a greater number of folds treated with RADIESSE
dermal filler were rated as "improved" or better at six and nine
months following treatment, as compared to the number of "improved"
or better Restylane folds. At nine months following second
treatment, 79% of folds treated with RADIESSE filler and 43% of
folds treated with Restylane filler showed improvement as measured
by the GAIS (p
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