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BTX-A Treatment for Palmar Hyperhidrosis

Primary Purpose

Primary Focal Hyperhidrosis of the Hands

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BTX-A
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Focal Hyperhidrosis of the Hands focused on measuring Primary focal hyperhidrosis, interdermal injections, iontophoresis, BTX-A

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Comparator of Hand A intervention vs Hand B

Arm Description

Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

Outcomes

Primary Outcome Measures

Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2010
Last Updated
January 13, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Allergan, Mattioli
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1. Study Identification

Unique Protocol Identification Number
NCT01262339
Brief Title
BTX-A Treatment for Palmar Hyperhidrosis
Official Title
Randomized, Single-blind Comparison of Botulinum Toxin Treatment for Palmar Hyperhidrosis Via Iontophoresis Versus Intradermal Injection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
low enrollment; principal investigator left sponsoring institution
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Allergan, Mattioli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Focal Hyperhidrosis of the Hands
Keywords
Primary focal hyperhidrosis, interdermal injections, iontophoresis, BTX-A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparator of Hand A intervention vs Hand B
Arm Type
Active Comparator
Arm Description
Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
Intervention Type
Drug
Intervention Name(s)
BTX-A
Other Intervention Name(s)
botulinum Toxin A
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53716
Country
United States

12. IPD Sharing Statement

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BTX-A Treatment for Palmar Hyperhidrosis

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