A Phase 2/3 interventional study of BTX-A in Primary Focal Hyperhidrosis of the Hands, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by University of Wisconsin, Madison · Phase 2/3, Interventional, and Treatment
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.
109 studies on the registry are indexed under Hyperhidrosis; 9 are open to participants now.
This study's enrollment of 2 is below the median of 53 across 98 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
Drug: 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
Also known as: botulinum Toxin A
Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.
Time frame: 26 weeks
| Milestone | Comparator of Hand A Intervention vs Hand B |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Comparator of Hand A Intervention vs Hand B | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Comparator of Hand A Intervention vs Hand B |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Comparator of Hand A Intervention vs Hand B |
|---|---|
| Female | 2 |
| Male | 0 |
| Region of Enrollment(participants) | Comparator of Hand A Intervention vs Hand B |
|---|---|
| United States | 2 |
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison