from the Spring 2005 issue
Frequently we are asked questions in our office about the claims made by various new anti-wrinkle creams and how effective they are. Over the last year there has been quite a stir raised by an ad campaign for StriVectin-SD® entitled “Better than BOTOX®?”
StriVectin-SD was originally marketed as a stretch-mark reducing cream but has most recently been touted as a facial anti-wrinkle product. On the better-than-BOTOX question, Basic Research, StriVectin’s exclusive distributor, believes it is better “because topical creams and gels offer gradual, continual results while the effects of injections wear off.” Basic Research further sites the limited FDA-approved treatment area (glabellar lines) and possible side effects as further proof, and says that clinical trials document that StriVectin-SD “significantly reduces the appearance of fine lines and facial wrinkles (including crow’s feet), the type of fine lines and wrinkles BOTOX treatments leave behind.” However, when asked by BusinessWeek On Line to provide information on where research on the product and its effectiveness was published, Klein-Becker, the maker of StriVectin, declined to do so.
StriVectin-SD is not alone in making such claims. Another cream, Hydroderm™, also raised the better-than-BOTOX question in its advertising. Hydroderm is promoted as “an anti-aging breakthrough” and offers the additional benefit of “no painful injections.” Hydroderm claims to deliver marine collagen through the upper layer of the skin deep into the lower layers of the epidermis through its patented collagen infusion technology. These are but two examples of products known as cosmeceuticals that make high-tech claims about their benefits. Unlike drugs, cosmeceuticals are not under the jurisdiction of the FDA, and therefore are not required to undergo double-blind scientific trials to prove their efficacy and safety. Most trials are conducted by the manufacturers themselves and the results, like StriVectin’s, are not published in the medical literature. This makes their claims difficult to verify or dispute. Furthermore, there are usually no head-to-head trials among competing products so substantiating which product is better is almost impossible.
To address the “Better than BOTOX®?” question scientifically, Dr. Kenneth Beer, a board-certified dermatologist from West Palm Beach, Florida, conducted a clinical trial comparing the efficacy and safety of BOTOX® Cosmetic, HydroDerm™, StriVectin-SD®, and WrinkleRelax™ for treating moderate-to-severe frown lines. Seventy-seven subjects were enrolled in the blind study and randomly assigned in equal number to one of five treatment groups. The fifth group received a placebo injection. The injections were given on day one of the study while the topicals were applied as directed throughout the 12-week trial. Follow-up visits took place at weeks 4, 8 and 12. All those who completed the 12-week masked portion of the trial were given an injection of BOTOX® Cosmetic in an open-label extension and assessed four weeks later. The results of the study were presented in September 2004 at the American Society for Dermatological Surgery annual meeting. They showed that the BOTOX treatment resulted in significantly greater reduction in wrinkle severity at each follow-up visit than did any of the three topical products or placebo injection from both the M.D. investigator’s and subjects’ assessments. Also a significantly higher percentage of subjects treated with BOTOX® rated the treatments as satisfactory or very satisfactory compared with subjects in the other treatment groups. As you would expect, four weeks after the open label injection of BOTOX, all study groups experienced substantially lower wrinkle severity with no significant differences among the groups. Dr. Beer concluded that the study demonstrated BOTOX’s superiority in reducing glabellar frown lines. He went on to state that although topical treatments may be an important part of any individual’s cosmetic regimen, they do not offer the same level of improvement as BOTOX. The full poster presentation of the study and its findings can be viewed by visiting the following website: www.palmbeachcosmetic.com/articles/82251599ASDSPoster.pdf.
Our years of experience with BOTOX® Cosmetic supports Dr. Beer’s findings. The vast majority of our patients get outstanding results with BOTOX® Cosmetic not only with the glabellar lines but also with crow’s feet and forehead lines. We also believe that topicals can improve the appearance of fine lines and wrinkles by helping the skin rebuild collagen. While we have not had experience with StriVectin-SD or the other products tested by Dr. Beer, we believe the gold standard of topicals are the Vitamin-A derivatives. Although “Better than BOTOX®?” may be an effective marketing campaign, based on the results that we have seen with BOTOX® Cosmetic, the answer is simply “No.”
For more information, see:
Big on BOTOX®Cosmetic
Winter 2008
The Wonders of
BOTOX®Cosmetic
Winter 2000
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