Status:
TERMINATED
BTX-A Treatment for Palmar Hyperhidrosis
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Allergan
Mattioli
Conditions:
Primary Focal Hyperhidrosis of the Hands
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting approximately 3% of the population in the United States. Not only that it is a major social embarrassment to affe...
Eligibility Criteria
Inclusion
- Healthy male or non-pregnant female
- Age 16 and older
- If \<18, parent/legal guardian willing to sign consent and accompany to visits
- Diagnosis of hyperhidrosis disease with a severity score (HDSS) of 3 or 4
- Treatment types of topical antiperspirants, iontophoresis, or systemic anticholinergics have failed to treat
- Able to come to 5 clinical visits during the study period
Exclusion
- Diagnosis of neuromuscular disease such as peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, or motor neuropathy)
- Diagnosis of neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome)
- Diagnosis of dysphagia
- Individuals with surgical implants such as pacemakers, orthopedic hardware, etc.
- Individuals who are Immunocompromised
- Systemic infectious illness or infection at the injection site(s)
- Known hypersensitivity to any ingredient in the formulation of the drug
- Organic cause of hyperhidrosis
- Known allergy to the ingredients in the general anesthesia
- Diagnosis of cardiac/pulmonary issues or disease
- Women who are pregnant or suspected to be pregnant
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01262339
Start Date
November 1 2010
End Date
November 1 2012
Last Update
January 26 2015
Active Locations (1)
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1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53716