[BACK TO ALL
ARTICLES]
First-Ever
Comparative Study Demonstrates Botox® Cosmetic More Effective in
Reducing Severity of Glabellar Lines Than Three Popular, Topical
Wrinkle Creams.
Source: PR Newswire Europe
Date: 10/2/2004
A new, first and only study comparing the safety and efficacy
of BOTOX(R) 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.
[BACK TO ALL
ARTICLES]
