Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (NCT00931359) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
United States120 participantsStarted 2009-06
Plain-language summary
This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).
Subjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.
All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.
Who can participate
Age range
18 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:
* baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla
* poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale
* primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria
* female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period
* female subjects over 40 must have had a mammogram in the last 2 years
* subjects must be willing to comply with study visits and requirements
Exclusion Criteria:
* subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)
* subject has active infection
* subject is pregnant or lactating
* subject has had prior surgery for axillary hyperhidrosis
* subject has had axillary injections of botulinum toxin A in the last year
* subject has used prescription antiperspirants in the last 14 days or plans to use them during the study period
* subject has used oral anticholinergics in the last 4 weeks
* subject is a prisoner or under incarceration
* subject is participating in a another clinical trial (or has in the last 30 days)
* subject has history of cancer (some exceptions)
* subject has a pacemaker or other electronic implant
* subject requires supplemental oxygen
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
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.