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NCT00168402 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 NCT00168402
Other study ID # 191622-046
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated May 27, 2011
Start date February 2002
Est. completion date October 2005

Study information
Verified date May 2011
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 study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.

Recruitment information / eligibility
Status Completed
Enrollment 193
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Marked axillary hyperhidrosis

Exclusion Criteria:

- Previous use of botulinum toxin for hyperhidrosis

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum Toxin Type A

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Outcome
Type Measure Description Time frame Safety issue
Primary Subject's assessment of the severity of hyperhidrosis
Secondary Measurement of axillary sweat production
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