Press Release From
Kenneth R. Beer, M.D., P.A.
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PALM BEACH, Fla., Nov. 24 - Enrollment
started today in the first clinical trial to compare the effectiveness and patient
satisfaction of BOTOX® Cosmetic with three cosmetic creams. The study will compare
BOTOX® Cosmetic with three over-the-counter creams - StriVectin-SD®, HydroDerm™,
and WrinkleRelax™ - for patients with moderate to severe glabellar lines (frown
lines between the brows).
The trial will be conducted by Dr.Kenneth Beer, a board-certified cosmetic dermatologist
at Palm Beach Esthetic Center, and clinical instructor of Dermatology at University
of Miami. "We have noticed a growing array of over-the-counter cosmetic creams
that are promising to provide patients the results of BOTOX® Cosmetic," said
Dr. Beer. "Unlike BOTOX® Cosmetic, which was approved by the FDA in April of
2002, these cosmetic creams are not approved by the FDA and physicians and consumers
need to understand the clinical benefit of these products through a direct comparison
of their efficacy and patient satisfaction."
Study Design
The study, to be called The Frown Line Challenge Trial, will enroll 75 patients
with moderate to severe frown lines. Patients will be randomly assigned to apply
StriVectin-SD®, HydroDerm™, or WrinkleRelax™ daily to their frown lines, or
to receive a single treatment of BOTOX® Cosmetic.
The products will be used appropriately and as advertised to consumers. Each
subject will be followed for four months to assess the effectiveness of the
treatment, and to determine satisfaction with the treatment. After four months
of follow-up, each of the patients randomized to topical treatment will
be offered BOTOX® Cosmetic in order to re-challenge the previously demonstrated
effects of the topical creams.
"The scientific premise in this study is very interesting to me as multiple
clinical trials have demonstrated the efficacy and safety of BOTOX® Cosmetic
yet no clinical trials are required by the FDA for over-the-counter consumer
creams," states Dr. Beer. "Our study will provide valuable
information to physicians recommending, and consumers selecting, a cosmetic
treatment."
If you live in south Florida and are interested in participation in this trial,
please contact Monica Yohn at 561-805-9911.
BOTOX® Cosmetic is a registered trademark of Allergan, Inc.StriVectin-SD® is
a registered trademark of Klein-Becker. HydroDerm™ is a registered trademark
of Spectrum Partners. WrinkleRelax™ is a registered trademark of Doctor's Dermatologic
Formula.
SOURCE Kenneth R. Beer, M.D., P.A.
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