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BTX-A Treatment for Palmar Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262339
Recruitment Status : Terminated (low enrollment; principal investigator left sponsoring institution)
First Posted : December 17, 2010
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

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 affected individuals, it also has significant negative impacts on career, school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from Clostridium bacteria, was approved by the U.S. Food & Drug Administration in 2004 for the treatment of severe focal axillary hyperhidrosis that does not respond to topical antiperspirants. It is becoming a promising treatment for many patients suffering this condition. Over the past decade, the medication has also been used effectively for many other forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin. Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are often limited by pain and post treatment muscle weakness associated with the procedure. Recent studies have demonstrated that BTX-A can be delivered across the skin via electric current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or Phoresor IIPM700). Studies with limited number of patients have demonstrated promising results with this new treatment.

Condition or disease Intervention/treatment Phase
Primary Focal Hyperhidrosis of the Hands Drug: BTX-A Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Single-blind Comparison of Botulinum Toxin Treatment for Palmar Hyperhidrosis Via Iontophoresis Versus Intradermal Injection
Study Start Date : November 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Comparator of Hand A intervention vs Hand B
Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
Drug: BTX-A
100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand
Other Name: botulinum Toxin A

Primary Outcome Measures :
  1. Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis. [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01262339

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United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53716
Sponsors and Collaborators
University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01262339    
Other Study ID Numbers: H-2009-0193
First Posted: December 17, 2010    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by University of Wisconsin, Madison:
Primary focal hyperhidrosis
interdermal injections
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs