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NCT00168480 Clinical Trial

A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

Hyperhidrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00168480
Other study ID # 191622-513
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 26, 2008
Start date November 2003
Est. completion date April 2007

Study information
Verified date September 2008
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a three year open-label study in subjects with axillary hyperhidrosis.

Recruitment information / eligibility
Status Completed
Enrollment 424
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Marked axillary hyperhidrosis

Exclusion Criteria:

- Previous use of botulinum toxin for hyperhidrosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Botulinum Toxin Type A
100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Germany,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of axillary sweat production Every 4 Months No
Secondary Patient reported health outcome measures 1 Month Post-Treatment Visit No
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