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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00168415
Other study ID # 191622-075
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 26, 2008
Start date August 2005
Est. completion date June 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

A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
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 up to 6 times during the study depending on the response to treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject's assessment of the severity of hyperhidrosis using the HDS Scale Monthly No
Secondary Measurement of axillary sweat production Week 4, Week 8 and any re-injection visit No
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