BTX-A Treatment for Palmar Hyperhidrosis

Phase 2

Terminated

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Comparator of Hand A intervention vs Hand B	BTX-A	Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

Primary Outcome Measures