Status:
TERMINATED
Miradry Treatment for Focal Axillary Hyperhidrosis
Lead Sponsor:
Johns Hopkins University
Conditions:
Axillary Hyperhidrosis
Eligibility:
All Genders
18-29 years
Phase:
NA
Brief Summary
Primary hyperhidrosis is a pathological condition characterized by the idiopathic and excessive secretion of sweat beyond normal physiological demand and is localized at particular foci such as the fa...
Detailed Description
Primary Objective: 1. To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Secondary Objectives: 2....
Eligibility Criteria
Inclusion
- This study will recruit patients diagnosed with focal hyperhidrosis with a known diagnosis of primarily axillary localization.
- We will only enroll patients available for both treatment visits. Availability for follow-up visit is optional.
- Only patients between the ages of 18 and 29 years when the first HHIQ is administered will be eligible.
- The upper age limit was so determined because patients over 29 years often present with psychopathology which is far more recalcitrant to correction of any kind regardless of effectiveness because of the duration of the condition.
- The lower age limit was so determined because 18 years and up are the ages for which the miraDry ® procedure has been approved for use by the FDA.
- All participants will be screened using the Hyperhidrosis Disease Severity Scale (HDSS).
- Only patients reporting their condition as a 3 out of 4 or higher on the HDSS will be eligible for study because preliminary data suggests effective detection of psychological changes only at higher reported levels of sweating severity.
- A patient's previous non-invasive treatment course, including but not limited to prescription of psychiatric medication and topical therapies, will not justify exclusion from this study.
Exclusion
- Patients who are unable to provide informed consent, have known allergies to lidocaine, hibiclens with 4% chlorhexidine, and/or epinephrine, are pregnant (as determined by self-reporting), are unable to take oral antibiotics or antiseptic washes, have heart pacemakers or other electronic device implants, and who need supplemental oxygen are not eligible to participate in this study
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02295891
Start Date
November 1 2014
End Date
December 1 2019
Last Update
May 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287