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PAPERS: M Naumann and N J Lowe Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial BMJ 2001; 323: 596 [Abstract] [Full text]

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Long-term treatment of axillary hyperhidrosis with botulinium toxin type A

Markus Naumann, NJ Lowe , CR Kumar and H Hamm on behalf of the Hyperhidrosis Clinical Investigators Group   (5 March 2002)

Long-term treatment of axillary hyperhidrosis with botulinium toxin type A 5 March 2002
Markus Naumann, Assistant Professor of Neurology Bayerische Julius-Maximilians-Universitat Wurzburg, Josef-Schneider Strasse 11, 97080 Wurzburg, Germ, NJ Lowe , CR Kumar and H Hamm on behalf of the Hyperhidrosis Clinical Investigators Group Send response to journal: Re: Long-term treatment of axillary hyperhidrosis with botulinium toxin type A	Further to our article published in BMJ volume 323 (Sept 2001) we would like to present the results of a long-term follow-up study designed to assess the long-term safety and efficacy of repeated injections of botulinum toxin type A (BOTOX®, Allergan, Inc) for the treatment of bilateral primary axillary hyperhidrosis. This represents the first systematic large scale study to assess the long term effects of this new treatment, with a study period of 16 months. Subjects included in the original study were randomised to receive either 50U botulinum toxin type A (BTX-A) or placebo per axilla. After a 4-month follow-up period subjects could then receive up to 3 further treatments with open-label BTX-A over the course of 12 months. Re- treatment was based on subject demand and the amount of sweat production, with sweat production being measured using the same methodology as used in the original study. Overall 356 BTX-A treatments were given to 207 subjects over the 16- month period (38.6% of subjects received one treatment, 44.9% received two treatments, and 14.5% received three treatments). No subjects had the maximum of four treatments allowed in the study. Mean duration between BTX-A treatments was 7 months, however, 28% of subjects continued to the end of the study period after only one BTX-A treatment. After placebo treatment the response rate (i.e. a 50% reduction from baseline in axillary sweating) at week 4 was 34.7%. After treatment with BTX-A response rates were 96.1%, 91.1% and 83.3% after the first, second and third treatments. Response rates were maintained at an assessment visit 16 weeks after each treatment. The size of the hyperhidrotic area also markedly decreased following each treatment. Subject satisfaction after treatments was consistently high, quality of life improved and impact of disease decreased after treatment. None of the 207 subjects treated developed antibodies against BTX-A following subsequent analysis. The safety profile over repeated treatments was excellent, with no increase in the number of adverse events following additional treatment cycles. Overall it can be concluded that long-term treatment with repeated intradermal injections of BTX-A is safe, efficacious and has a positive impact on subject’s quality of life.