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
  Purpose

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 Intervention Phase
Primary Focal Hyperhidrosis of the Hands
Drug: BTX-A
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Single-blind Comparison of Botulinum Toxin Treatment for Palmar Hyperhidrosis Via Iontophoresis Versus Intradermal Injection

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BTX-A
    100 units of BTX-A will be delivered to the subject's hand via iontophoresis
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262339

Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53716
Sponsors and Collaborators
University of Wisconsin, Madison
Allergan
Mattioli
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01262339     History of Changes
Other Study ID Numbers: H-2009-0193
Study First Received: December 15, 2010
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Primary focal hyperhidrosis
interdermal injections
iontophoresis
BTX-A

Additional relevant MeSH terms:
Hyperhidrosis
Skin Diseases
Sweat Gland Diseases

ClinicalTrials.gov processed this record on October 21, 2014