Trial Outcomes & Findings for Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis) (NCT NCT01274611)
NCT ID: NCT01274611
Last Updated: 2021-12-06
Results Overview
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.
COMPLETED
NA
20 participants
baseline and 3 months
2021-12-06
Participant Flow
Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.
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.
Participant milestones
| Measure |
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 was 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.
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
Baseline characteristics by cohort
| Measure |
Subjects Receiving Split Body Treatment
n=20 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 monthsThe 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.
Outcome measures
| Measure |
Botox
n=20 axillae
Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
|
Suction-Curettage
n=20 axillae
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.
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|---|---|---|
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Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
|
73.8 Percentage Change
Interval 20.0 to 100.0
|
58.8 Percentage Change
Interval 2.0 to 94.0
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SECONDARY outcome
Timeframe: Baseline and 3 monthsChange 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.
Outcome measures
| Measure |
Botox
n=20 axillae
Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
|
Suction-Curettage
n=20 axillae
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.
|
|---|---|---|
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The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
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1.55 Scores on a scale
Standard Deviation 0.68633
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0.08 Scores on a scale
Standard Deviation 0.83351
|
Adverse Events
Botox
Suction-Curettage
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place