Primary Focal Hyperhidrosis of the Hands Clinical Trial
Official title:
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | November 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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 |
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Wisconsin-Madison | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Wisconsin, Madison | Allergan, Mattioli |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis. | 26 weeks | Yes |