SANTA MONICA, Calif. -- A new study comparing the safety and efficacy of two different formulations of botulinum toxin type A in the treatment of glabellar lines shows that patients are significantly more satisfied with their appearance after treatment with BOTOX Cosmetic (20 units, the dose approved by the U.S. Food and Drug Administration for the treatment of glabellar lines) than with Dysport (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 were presented at the American Society for Dermatological Surgery (ASDS) annual meeting in San Diego last week.
"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, MD, 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, Calif.
"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).
Nicholas J. Lowe, MD, 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