BTX-A Treatment for Palmar Hyperhidrosis (NCT01262339) | Clinical Trial Compass
TerminatedPhase 2/3
BTX-A Treatment for Palmar Hyperhidrosis
Stopped: low enrollment; principal investigator left sponsoring institution
United States2 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.