Primary Focal Hyperhidrosis of the Hands
Conditions
Keywords
Primary focal hyperhidrosis, interdermal injections, iontophoresis, BTX-A
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.
Interventions
DRUGBTX-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
Sponsors
Allergan
Mattioli
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis. | 26 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Comparator of Hand A Intervention vs Hand B |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.
Time frame: 26 weeks
Population: Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.