Study Comparing Botox to Wrinkle Creams

First-Ever Comparative Study Demonstrates BOTOX(R) Cosmetic More Effective in Reducing Severity of Glabellar Lines Than Three Popular, Topical Wrinkle Creams

(press release from Kenneth R. Beer, M.D., P.A.

WEST PALM BEACH, Fla., Oct. 2 -- 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.

About Dr. Beer:

Kenneth Beer, M.D. received his medical degree from The University of Pennsylvania in 1989, and completed his dermatology residency and dermatopathology at The University of Chicago. Dr. Beer is board certified in dermatology by The American Board of Dermatology and is also board certified in dermatopathology. He is a voluntary clinical instructor in dermatology at the University of Miami and has published several articles, is a frequent writer for popular magazines such as Elle and Allure and can be seen on television news programs. Dr. Beer is a fellow of the American Academy of Dermatology, the American Society for Dermatopathology, the American Society for Dermatologic Surgery (where he serves on the Branding and Public Service Committees), the American Society for Mohs Surgery and numerous other professional organizations. He is an expert for the State of Florida Agency for Healthcare and teaches at the American Academy of Dermatology annual meetings on Restylane and BOTOX Cosmetic injection techniques and other soft tissue augmentation procedures. Dr. Beer has written several articles on cosmetic dermatology and writes for a monthly cosmetic column in Skin and Aging magazine and has authored several chapters in cosmetic dermatology textbooks.

About Palm Beach Esthetic Center:

The Palm Beach Esthetic Center is a cosmetic dermatology practice that provides the finest patient care available. The Esthetic Center is an active clinical trial center that conducts studies on novel skin cancer treatments, cosmetic procedures, treatments for acne, psoriasis and other skin diseases. The Center has a full complement of lasers as well as a full time esthetician that can care for every aspect of patients' skin care needs. The Palm Beach Esthetic Center provides personalized skin care and cosmetic services in a warm environment

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