Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis) (NCT01274611) | Clinical Trial Compass
CompletedNot Applicable
Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
United States20 participantsStarted 2010-12
Plain-language summary
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
Who can participate
Age range
18 Years – 65 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:
* Ages 18 to 65
* BMI 18.5 - 29.99
* Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
* Subject is in good health
* Subject has the willingness and ability to understand and provide informed consent
Exclusion Criteria:
* Under age 18 or over age 65
* Pregnancy or lactating
* BMI ≥ 30 or ≤18.4
* Subjects who have undergone axillary suction/curettage any time in the past
* Subjects who have undergone axillary BT-A injections in the past year
* Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
* Subjects with a history of a bleeding disorder
* Subjects with an open, non-healing sore or infection near site of procedure
* Subjects with allergies to iodine, starch powder, albumin, or any botulinum toxin product
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 Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months