BTX-A Treatment for Palmar Hyperhidrosis

NCT ID: NCT01262339

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Primary Focal Hyperhidrosis of the Hands

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BTX-A

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

botulinum Toxin A

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Mattioli

UNKNOWN

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2009-0193

Identifier Type: -

Identifier Source: org_study_id