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NCT01262339 · ClinicalTrials.gov registry record · Phase 2
BTX-A Treatment for Palmar Hyperhidrosis
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01262339 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 2 participants.
The verdict
NCT01262339, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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
- DRUG BTX-A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01262339
The ClinicalTrials.gov registry entry for NCT01262339 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BTX-A is the first listed.
NCT01262339 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01262339 about?
NCT01262339 is a clinical study titled "BTX-A Treatment for Palmar Hyperhidrosis". 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. Botu...
What is the current status of trial NCT01262339?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2010-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01262339?
The interventions under investigation include: BTX-A (DRUG).
Who is sponsoring clinical trial NCT01262339?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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