Axillary Hyperhidrosis
Conditions
Keywords
hyperhidrosis, botox, liposuction, suction-curettage, suction, curettage, sweating, sweat, underarm, axillary
Brief 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.
Interventions
DRUGBotulinum Toxin Type A
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
DEVICESuction-Curettage
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months | baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment | Baseline and 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.
Pre-assignment details
This was a split body, parallel-group randomized control trial with allocation ratio 1:1, using random block size of 2. The unit of randomization was the individual axilla.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Split Body Treatment The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.
Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.
For Suction-Curettage, the doctor inserted 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Subjects Receiving Split Body Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 30.9 years STANDARD_DEVIATION 8.67 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Botox | Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months | 73.8 Percentage Change |
| Suction-Curettage | Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months | 58.8 Percentage Change |
p-value: >0.01t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox | The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment | 1.55 Scores on a scale | Standard Deviation 0.68633 |
| Suction-Curettage | The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment | 0.08 Scores on a scale | Standard Deviation 0.83351 |
p-value: <0.01t-test, 2 sided