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Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7313.596 (Published 15 September 2001) Cite this as: BMJ 2001;323:596

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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.

Competing interests: No competing interests

05 March 2002
Markus Naumann
Assistant Professor of Neurology
NJ Lowe , CR Kumar and H Hamm on behalf of the Hyperhidrosis Clinical Investigators Group
Bayerische Julius-Maximilians-Universitat Wurzburg, Josef-Schneider Strasse 11, 97080 Wurzburg, Germ