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Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)

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ClinicalTrials.gov Identifier: NCT01274611
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : February 3, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Axillary Hyperhidrosis
Interventions Drug: Botulinum Toxin Type A
Device: Suction-Curettage
Enrollment 20
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.
Arm/Group Title Subjects Receiving Split Body Treatment
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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.

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Subjects Receiving Split Body Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
30.9  (8.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
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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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botox Suction-Curettage
Hide Arm/Group Description:
Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
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.
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Axillae
20 20
Mean (Full Range)
Unit of Measure: Percentage Change
73.8
(20 to 100)
58.8
(2 to 94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Botox, Suction-Curettage
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
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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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botox Suction-Curettage
Hide Arm/Group Description:
Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
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.
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Axillae
20 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.55  (0.68633) 0.08  (0.83351)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Botox, Suction-Curettage
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.80
Estimation Comments [Not Specified]
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botox Suction-Curettage
Hide Arm/Group Description Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating. 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.
All-Cause Mortality
Botox Suction-Curettage
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botox Suction-Curettage
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botox Suction-Curettage
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
There was a the lack of long-term assessment of comparative effectiveness. It is uncertain whether suction-curettage removes the eccrine sweat glands or mainly the apocrine glands.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Murad Alam
Organization: Northwestern University
Phone: 312-695-4761
EMail: m-alam@northwestern.edu
Layout table for additonal information
Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT01274611     History of Changes
Other Study ID Numbers: STU40780
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: July 18, 2013
Results First Posted: February 3, 2014
Last Update Posted: August 15, 2014