Background: Botulinum toxin type B (BTX-B) is U.S. Food and Drug Administration (FDA)-approved for the treatment of cervical dystonia. There are no published studies investigating its efficacy for treatment of glabellar (frown) wrinkles; however, anecdotal reports of its efficacy are promising.
Objective: The current pilot study is an initial screening study to assess the safety and efficacy of a single, set dose of BTX-B in the treatment of glabellar (frown) lines and to document current clinical experience with BTX-B.
Methods: Thirty subjects (28 women, 2 men) were injected in six sites with 300 U per site for a total dose of 1800 U.
Results: At 2 and 4 weeks, patient and physician assessment scores showed an average score of 2 ("complete disappearance of wrinkles"). Three patients reported mild adverse events.
Conclusion: Injections of BTX-B proved to be very efficacious, with rapid onset, with all patients responding within 3 days (mean 1.5 days). Adverse events were mild. The mean duration of effect with this low dose of BTX-B was 8 weeks. Since the duration may be dose related and minimal adverse events were observed at 1800 U, further studies are in progress to look at the duration of response resulting from higher doses of BTX-B in the treatment of glabellar wrinkles.