Histological Analysis Following Ulthera System Treatment for Hyperhidrosis (NCT01708551) | Clinical Trial Compass
CompletedNot Applicable
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
United States59 participantsStarted 2012-08
Plain-language summary
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
Who can participate
Age range
18 Years – 75 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, ages 18-75
* Subject is in good health
* Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
* Groups A, C, D and E: At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature / humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.) Group B: A mean of \>50mg/5min of sweat production following a prior Ultherapy treatment.
* A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Absence of physical conditions unacceptable to the investigator.
* Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.
Exclusion Criteria:
* Dermal disorder including infection at anticipated treatment sites in either axilla.
* Previous botulinum toxin treatment of the axilla in the past year.
* Expected use of botulinum toxin for the treatment of any other disease during the study period.
* Known allergy to starch pow…
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
Reduction in the number of sweat glands from baseline to 90-days post-treatment.