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.

Study Overview

• Status: Terminated
• Conditions: Primary Focal Hyperhidrosis of the Hands
• Intervention / Treatment: Drug: BTX-A

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53716
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: botulinum Toxin A

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Allergan; Mattioli

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Primary focal hyperhidrosis; interdermal injections; iontophoresis; BTX-A
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A
• Other Study ID Numbers: H-2009-0193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No