WEST PALM BEACH, Fla., Oct. 2 /PRNewswire/ — A new, first and only study comparing the safety and efficacy of BOTOX® Cosmetic to three over-the- counter, topical wrinkle creams (HydroDerm(TM), StriVectin-SD(TM) and Wrinkle Relax(TM)) demonstrates that BOTOX Cosmetic is significantly more effective than these products at reducing the appearance of moderate-to-severe glabellar lines (frown lines between the brow). All treatments included in the study were well-tolerated. The study results are being presented at the American Society for Dermatological Surgery (ASDS) and American College of Mohs Micrographic Surgery and Cutaneous Oncology (ACMMSCO) Combined Annual Meeting from September 30 – October 3, 2004 in San Diego.
“A growing array of over-the-counter cosmetic creams, which are often used by consumers for fine lines and wrinkles, claim in advertisements they are as effective as BOTOX Cosmetic. But until now, no comparative data has been published to support these claims,” said Kenneth Beer, M.D., P.A., dermatologist at the Palm Beach Esthetic Center and dermatology instructor at the University of Miami, who authored the study. “This first-ever study demonstrates that while topical cosmetic creams may diminish the appearance of some fine lines, they do not offer the same level of improvement in moderate- to-severe glabellar lines as BOTOX Cosmetic.”
Dr. Beer concluded, “The findings provide physicians and consumers with clinical data to effectively answer questions and help them make more informed treatment decisions.”
The study was a randomized, investigator-masked, 12-week parallel study involving 77 female subjects randomized into one of five treatment groups: BOTOX Cosmetic injection, placebo injection (0.9% saline), HydroDerm, StriVectin-SD or Wrinkle Relax. All subjects were given a baseline evaluation and attended follow-up visits at weeks 4, 8 and 12. At the baseline visit, BOTOX Cosmetic or placebo was administered to the injector group in five injections of 0.1 mL each: two in each corrugator muscle and one in the procerus muscle. Those in the topical cream group were instructed by staff members on the proper use of topical study treatments, which were applied daily. Key efficacy measures included: blinded investigator assessment of glabellar line severity and subject global assessment of overall change in appearance.
At week 4, more than 86 percent of subjects treated with BOTOX Cosmetic exhibited a 50 percent or greater improvement in wrinkle severity, as assessed using the Patient Global Assessment of Improvement Scale. In contrast, the majority of subjects in the topical treatment and placebo injection groups exhibited less than 50 percent improvement in wrinkle severity. At each follow up visit, subjects were significantly more satisfied with BOTOX Cosmetic than with any other treatment. At weeks 4, 8 and 12, physician assessments using the Facial Wrinkle Scale showed treatment with BOTOX Cosmetic resulted in a significantly greater reduction in wrinkle severity than any other treatment (p<.001). The wrinkle reduction associated with topical treatments did not differ from placebo at any time.
At the end of the masked study period, all study participants were offered an open-label BOTOX Cosmetic injection and were evaluated four weeks later. At the open-label evaluation, treatment with BOTOX Cosmetic resulted in substantially lower wrinkle severity in all study groups. No significant differences between the study groups were observed.
No adverse events (AEs) were reported by subjects who received BOTOX Cosmetic or placebo injections, HydroDerm or Wrinkle Relax. In the StriVectin- SD group, three separate AEs were reported by three subjects: flushing (not likely to be drug-related), redness and itching.
This study was supported by an unrestricted educational grant from Allergan, Inc.; other manufacturers of the products used in this study were invited to support this research but declined.