Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suction-Curettage | Active Comparator |
| |
| Botox | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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...
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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alejandra Onate, M.S. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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.
Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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...
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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 months | axillae | axillae |
|
7 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botox | Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Murad Alam | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D014619 | Vacuum Curettage |
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Suction-Curettage | Device | 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. |
|
|
| Baseline and 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Botox |
Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating. |
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Full Range | Percentage Change | baseline and 3 months | axillae | axillae |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004107 | Dilatation and Curettage |
| D003475 | Curettage |
| D013514 | Surgical Procedures, Operative |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D019651 | Plastic Surgery Procedures |