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Patients More Satisfied With Appearance After Treatment With BOTOX(R) Cosmetic Than With Dysport(R) - and Effects Last Longer - According to New Study

(press release from Dr. Nicolas J. Lowe, M.D.)

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SANTA MONICA, Calif., and LONDON, Oct. 2-- A new study comparing the safety and efficacy of two different formulations of botulinum toxin type A in the treatment of glabellar lines (the vertical "frown lines" between the brows) shows that patients are significantly more satisfied with their appearance after treatment with BOTOX(R) Cosmetic (20 units, the dose approved by the U.S. Food and Drug Administration for the treatment of glabellar lines) than with Dysport(R) (50 units, reported to be the optimal dose for this formulation), a formulation of botulinum toxin type A not yet approved for use in North America. The study also demonstrated that effects of treatment with BOTOX Cosmetic last longer than the treatment effects of Dysport. Both treatments were well-tolerated. The study findings are being presented at the American Society for Dermatological Surgery (ASDS) Annual Meeting from September 30 - October 3, 2004 in San Diego.

"In this study, treatment with BOTOX Cosmetic offered superior results in terms of both patient satisfaction with appearance and objective physician ratings of glabellar line severity," said Nicholas J. Lowe, M.D., clinical professor of dermatology at the UCLA School of Medicine in Los Angeles and dermatologist at the Cranley Clinic London and the Southern California Dermatology and Laser Center in Santa Monica, CA. "This is the first head-to- head research of these two products in this use, and these findings help fill a gap in our knowledge about how different formulations of botulinum toxin type A compare in terms of efficacy and duration. Our results are consistent with studies other uses showing that different formulations of botulinum toxin type A behave in different ways, and that results obtained with one formulation cannot be extended to another."

This study was a randomized, double-blind study involving 30 patients up to 55 years of age (mean age, 42) with glabellar lines of at least moderate severity. Study participants were randomly assigned to receive BOTOX Cosmetic 20U or Dysport 50U (in five injections, 1 in the procerus muscle and 2 in each of the corrugator muscles). Patient evaluation of satisfaction with appearance was measured on a scale of 0 (not at all satisfied with appearance) to 6 (extremely satisfied with appearance). Glabellar line severity was rated by investigators who assessed standardized post-treatment photographs of study participants without knowing which treatment they had received.

The study found that patients' treated with BOTOX Cosmetic were significantly more satisfied with the improvement in their appearance than were patients treated with Dysport (p<.01 at week 12). At week 12, sixty-four percent of patients treated with BOTOX Cosmetic reported experiencing a 50 percent or greater improvement in glabellar line severity, compared to just 33 percent of Dysport-treated patients.

"The patient satisfaction results are particularly noteworthy because, although these are subjective evaluations, the patient's judgment is extremely important in the evaluation of cosmetic treatments," said Dr. Lowe.

In addition, the effects of treatment lasted longer with BOTOX Cosmetic than with Dysport. At week twelve, 47 percent of BOTOX Cosmetic patients were still classified as responders (with glabellar line severity rated as none or mild during a forced muscle contraction) compared to just 21 percent of the Dysport-treated patients. Both treatments were well-tolerated; only one adverse event was reported that may have been related to treatment (mild bruising in one patient in the BOTOX Cosmetic group).

BOTOX Cosmetic is available in the U.S. and Canada, as VISTABEL(R) in most European countries, and as VISTABEX(TM) in Italy.

This study was supported by an unrestricted educational grant from Allergan, Inc. and was conducted at the Cranley Clinic in Dermatology in London, England.

Dr. Lowe divides his time between his private practices and clinical research centers in London and Santa Monica.

About Dr. Lowe:

Nicholas J. Lowe, M.D. received his medical degree from The University of Liverpool Medical School in the United Kingdom in 1968. He completed his medical residency at the Royal Naval Hospital in Hampshire, UK, his dermatology residency and fellowship residency at the University of California at the San Diego School of Medicine, and received a Research Fellowship in Dermatology at the Scripps Clinic and Research Foundation in La Jolla, California. Dr. Lowe is board certified in dermatology by The American Board of Dermatology and a dermatology specialist in the UK. He is clinical professor of dermatology at the UCLA School of Medicine in Los Angeles, and Senior Lecturer and Consultant in Dermatology, University College, London. He is founding editor of the Journal of Cosmetic and Laser Therapy and is a member of numerous professional organizations

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