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

Details

Serval ID
serval:BIB_A1A90388DB4B
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial.
Journal
BMJ
Author(s)
Naumann M., Lowe N.J.
ISSN
0959-8138
Publication state
Published
Issued date
2001
Peer-reviewed
Oui
Volume
323
Number
7313
Pages
596-599
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Abstract
OBJECTIVES: To evaluate the safety and efficacy of botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis. DESIGN: Multicentre, randomised, parallel group, placebo controlled trial. SETTING: 17 dermatology and neurology clinics in Belgium, Germany, Switzerland, and the United Kingdom. PARTICIPANTS: Patients aged 18-75 years with bilateral primary axillary hyperhidrosis sufficient to interfere with daily living. 465 were screened, 320 randomised, and 307 completed the study. INTERVENTIONS: Patients received either botulinum toxin type A (Botox) 50 U per axilla or placebo by 10-15 intradermal injections evenly distributed within the hyperhydrotic area of each axilla, defined by Minor's iodine starch test. MAIN OUTCOME MEASURES: Percentage of responders (patients with >/=50% reduction from baseline of spontaneous axillary sweat production) at four weeks, patients' global assessment of treatment satisfaction score, and adverse events. RESULTS: At four weeks, 94% (227) of the botulinum toxin type A group had responded compared with 36% (28) of the placebo group. By week 16, response rates were 82% (198) and 21% (16), respectively. The results for all other measures of efficacy were significantly better in the botulinum toxin group than the placebo group. Significantly higher patient satisfaction was reported in the botulinum toxin type A group than the placebo group (3.3 v 0.8, P<0.001 at 4 weeks). Adverse events were reported by only 27 patients (11%) in the botulinum toxin group and four (5%) in the placebo group (P>0.05). CONCLUSION: Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction.
Keywords
Adolescent, Adult, Aged, Axilla, Botulinum Toxin Type A/adverse effects, Botulinum Toxin Type A/therapeutic use, Double-Blind Method, Humans, Hyperhidrosis/drug therapy, Middle Aged, Neuromuscular Agents/adverse effects, Neuromuscular Agents/therapeutic use, Patient Satisfaction, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
25/01/2008 16:36
Last modification date
20/08/2019 15:07
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