BTX-A Treatment for Palmar Hyperhidrosis

NCT01262339 | Terminated Phase 2 Results DMC

• 1 other identifier: H-2009-0193
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

Primary focal hyperhidrosis; interdermal injections; iontophoresis; BTX-A

Outcome Measures

Primary Outcomes (1)

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

  26 weeks

Study Arms (1)

Comparator of Hand A intervention vs Hand B

ACTIVE COMPARATOR

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

Drug: BTX-A

Interventions

BTX-A 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

Also known as: botulinum Toxin A

Comparator of Hand A intervention vs Hand B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Allergan: collaborator
• Mattioli: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53716, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dermatology Clinical Trials Administrator
• Organization: University of Wisconsin- Madison

dbock@dermatology.wisc.edu

608-287-2640

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

US (1)