Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New data show botulinum toxin type A to be highly effective treatment for excessive sweating

09.02.2004


Results of a Phase III clinical study using botulinum toxin type A to treat primary axillary hyperhidrosis, or excessive underarm sweating, show that botulinum toxin type A is safe and effective for treatment of hyperhidrosis and that it markedly improves quality of life in patients who suffer from this medical condition. The data were announced today at the 2004 American Academy of Dermatology (AAD) annual meeting in Washington, D.C. by Dr. Dee Anna Glaser, Associate Professor of Dermatology and Vice Chairman, Department of Dermatology, at Saint Louis University School of Medicine, a lead investigator for the trials.



"Most people don’t realize that hyperhidrosis is an extremely debilitating chronic condition that affects as many as eight million people in the U.S.," said Dr. Glaser. "As such, the results of this 52-week study using botulinum toxin type A treatment are very exciting because they mean that we are that much closer to having the first truly effective, non-surgical treatment available to meet the needs of patients who suffer from primary axillary hyperhidrosis."

The study found that four weeks after treatment with botulinum toxin type A (administered intradermally), 75 percent of patients receiving botulinum toxin type A vs. 25 percent on placebo achieved at least a 2-point improvement from baseline on the Hyperhidrosis Severity Scale (HDSS), a 4-point scale. Quantity of sweat production in the axillae was also significantly decreased.


"The Hyperhidrosis Severity Scale is an important new tool that physicians can use to identify hyperhidrosis patients who are in need of medical treatment, as well as to assess treatment results over time," explains Dr. Glaser. "It is our hope that physicians will begin to use this valid and reliable scale to quickly and accurately diagnose patients with hyperhidrosis who otherwise might not seek treatment."

The study also assessed the specific effects of primary axillary hyperhidrosis on patients’ daily lives at study entry (prior to receiving treatment) and again four weeks after receiving his/her study treatment. It found that hyperhidrosis results in substantial occupational, psychological and physical impairment for the patient, and that botulinum toxin type A treatment markedly improved patients’ quality of life as soon as four weeks after initial treatment.

"People who suffer from hyperhidrosis have a very hard time leading a normal life," said Dr. Glaser. "While there is a general misperception that hyperhidrosis is merely a disturbing hygienic issue, the condition should be taken seriously as it could lead to isolation and depression. It is important that physicians are made aware of hyperhidrosis and available treatment options to ensure patients receive proper diagnosis and are not just sent away with instructions to buy a stronger anti-perspirant."

Safety and Efficacy - Methodology and Results

Following screening, 322 patients were randomized to one of three treatment groups (50 units of botulinum toxin type A per underarm, 75 units of botulinum toxin type A per underam or placebo) and were evaluated at one week after treatment and every four weeks thereafter. The primary efficacy evaluation was patient assessment of hyperhidrosis severity using the Hyperhidrosis Disease Severity Scale (HDSS).

Four weeks after treatment session one, the following results were observed:
  • 75 percent of patients in each botulinum toxin type A group and 25 percent of placebo patients achieved at least a two-grade improvement from baseline on the HDSS;

  • 43 percent of patients treated with botulinum toxin type A required only one treatment for the entire one-year study period, versus 12 percent on placebo;

  • Mean sweat production was significantly decreased in both botulinum toxin type A groups four weeks after their initial treatment (82 percent, 87 percent and 22 percent decreases in the 50U, 75U and placebo groups respectively);

  • Upon completion of the study, 85 percent and 84 percent of patients treated with 50U and 75U of botulinum toxin type A respectively reported that they were much more satisfied with the current study treatment than with previous treatments, versus 20 percent of patients on placebo;

  • There was no difference between the 50U and 75U groups in terms of measured efficacy endpoints.

No serious treatment-related adverse events were reported. The most frequently reported treatment-related adverse events (>5 percent in any treatment group) were injection site pain, injection site hemorrhage and non-axillary sweating. The incidence of these events was not significantly different between groups.

In related research presented by Dr. Glaser at the meeting, data from the 322 patient study were used to assess the validity of the HDSS by correlating HDSS scores with items from the Dermatology Quality of Life Index and the HHIQ four weeks post-treatment. Construct validity and responsiveness were assessed by comparing post-treatment changes in HDSS score with changes in gravimetric sweat measurement and by comparing HDSS scores with various daily activity limitations due to excessive sweating as collected in a national survey mailed to 150,000 U.S. households.

Based on resulting data from these analyses, the HDSS was observed to have acceptable validity, reliability and responsiveness.


This study was funded by Allergan, Inc.

Joe Muehlenkamp | EurekAlert!
Further information:
http://www.slu.edu/

More articles from Health and Medicine:

nachricht On track to heal leukaemia
18.01.2017 | Universitätsspital Bern

nachricht Penn vet research identifies new target for taming Ebola
12.01.2017 | University of Pennsylvania

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

Im Focus: Designing Architecture with Solar Building Envelopes

Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.

As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...

Im Focus: How to inflate a hardened concrete shell with a weight of 80 t

At TU Wien, an alternative for resource intensive formwork for the construction of concrete domes was developed. It is now used in a test dome for the Austrian Federal Railways Infrastructure (ÖBB Infrastruktur).

Concrete shells are efficient structures, but not very resource efficient. The formwork for the construction of concrete domes alone requires a high amount of...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

Nothing will happen without batteries making it happen!

05.01.2017 | Event News

 
Latest News

A big nano boost for solar cells

18.01.2017 | Power and Electrical Engineering

Glass's off-kilter harmonies

18.01.2017 | Materials Sciences

Toward a 'smart' patch that automatically delivers insulin when needed

18.01.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>