A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis (NCT01722461) | Clinical Trial Compass
TerminatedNot Applicable
A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Stopped: Sponsor decision; unexpectedly high sham response at primary outcome time point.
United States120 participantsStarted 2012-11
Plain-language summary
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.
Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater 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 and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
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:
* Male and female, age 18 years or older.
* Subject is in good health.
* Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
* At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
* A HDSS score of 3 or 4
* Willingness to comply with study visits and requirements
* Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1
* Female subjects over 40 years of age must have had a mammogram in the last 2 years
Exclusion Criteria:
* Has a dermal disorder including infection at anticipated treatment sites in either axilla.
* Has had axillary injections of botulinum toxin in the last year.
* Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
* Has a known allergy to starch powder, iodine, or lidocaine.
* Has secondary hyperhidrosis
* Has had previous surgical treatment of hyperhidrosis
* Has had prior miraDry treatment for axillary hyperhidrosis.
* Has used prescription antiperspirants in the last 14 days or plans to use them during the study period.
* Inability to withhold use of non-study-supplied antiperspirants and deodorants
* Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments.
* History of previous Ultherapy™ treatment to the axilla.
* Has a history of a …
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 active treated subjects compared to sham treated subjects with reduced underarm sweating