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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborators:
Allergan Mattioli
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA