BTX-A Treatment for Palmar Hyperhidrosis

This study has been terminated.
(low enrollment)
Sponsor:
Collaborators:
Allergan
Mattioli
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01262339
First received: December 15, 2010
Last updated: June 25, 2013
Last verified: June 2013

December 15, 2010
June 25, 2013
November 2010
April 2012   (final data collection date for primary outcome measure)
Evaluate the efficacy of Botulinum Toxin A (BTX-A) in the treatment of primary palmar hyperhidrosis delivered via iontophoresis. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01262339 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
BTX-A Treatment for Palmar Hyperhidrosis
Randomized, Single-blind Comparison of Botulinum Toxin Treatment for Palmar Hyperhidrosis Via Iontophoresis Versus Intradermal Injection

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Primary Focal Hyperhidrosis of the Hands
Drug: BTX-A
100 units of BTX-A will be delivered to the subject's hand via iontophoresis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
November 2012
April 2012   (final data collection date for primary outcome measure)

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. anyotrophic 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262339
H-2009-0193
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
  • Allergan
  • Mattioli
Not Provided
University of Wisconsin, Madison
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP