A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
This study has been completed.
Sponsor:
Allergan
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168402
First received: September 13, 2005
Last updated: May 27, 2011
Last verified: May 2011
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Purpose
This is a three-year study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperhidrosis |
Drug: Botulinum Toxin Type A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Subject's assessment of the severity of hyperhidrosis
Secondary Outcome Measures:
- Measurement of axillary sweat production
| Enrollment: | 193 |
| Study Start Date: | February 2002 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Marked axillary hyperhidrosis
Exclusion Criteria:
- Previous use of botulinum toxin for hyperhidrosis
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Therapeutic Area Head, Allergan, Inc |
| ClinicalTrials.gov Identifier: | NCT00168402 History of Changes |
| Other Study ID Numbers: | 191622-046 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Allergan:
|
Axillary Hyperhidrosis |
Additional relevant MeSH terms:
|
Hyperhidrosis Sweat Gland Diseases Skin Diseases Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013