An interventional study of Botulinum Toxin Type A and Suction-Curettage in Axillary Hyperhidrosis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Suction-Curettage
Drug: Botulinum Toxin Type A
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
Also known as: botox
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 to decrease underarm sweating.
Also known as: liposuction
Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment. This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes. Percentage sweat rate was calculated as \[(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline\]\*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate.
Time frame: baseline and 3 months
The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment. The HDSS iquestionnaire assigns a point value to the patient's view: My sweating is... 1. never noticeable and never interferes with my daily activities 2. tolerable but sometimes interferes with my daily activities 3. barely tolerable and frequently interferes with my daily activities 4. intolerable and always interferes with my daily activities Lower point values are considered better and higher point values are considered worse. A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment.
Time frame: Baseline and 3 months
Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.
| Milestone | Subjects Receiving Split Body Treatment |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment. The HDSS iquestionnaire assigns a point value to the patient's view: My sweating is... 1. never noticeable and never interferes with my daily activities 2. tolerable but sometimes interferes with my daily activities 3. barely tolerable and frequently interferes with my daily activities 4. intolerable and always interferes with my daily activities Lower point values are considered better and higher point values are considered worse. A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment.
| Scores on a scale | Botox | Suction-Curettage |
|---|---|---|
| The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment | 1.55 ± 0.68633 | 0.08 ± 0.83351 |
The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment. This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes. Percentage sweat rate was calculated as \[(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline\]\*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate.
| Percentage Change | Botox | Suction-Curettage |
|---|---|---|
| Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months | 73.8 (20 to 100) | 58.8 (2 to 94) |
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botox | — | 0/20 (0%) | 0/20 (0%) |
| Suction-Curettage | — | 0/20 (0%) | 0/20 (0%) |
This was a parallel-group randomized control trial with allocation ratio 1:1, using random block size of 2. The unit of randomization was the individual axilla.
| Age, Categorical(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age, Continuous(years) | Subjects Receiving Split Body Treatment |
|---|---|
| Mean | 30.9 ± 8.67 |
| Sex: Female, Male(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| Female | 7 |
| Male | 13 |
| Region of Enrollment(participants) | Subjects Receiving Split Body Treatment |
|---|---|
| United States | 20 |
The record gives a start of Dec 2010, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 2 years 2 months after primary completion.
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A