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

Study Overview
=================
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.

Official Title
-----------------
Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis

Conditions
-----------------
Axillary Hyperhidrosis

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Device: Suction-Curettage


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suction-Curettage<br> | Device: Suction-Curettage<br>* 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.<br>* Other names: liposuction;|
| Experimental: Botox<br> | Drug: Botulinum Toxin Type A<br>* Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.<br>* Other names: botox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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... never noticeable and never interferes with my daily activities tolerable but sometimes interferes with my daily activities barely tolerable and frequently interferes with my daily activities 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. | Baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sweating, sweat, underarm, axillary, hyperhidrosis, botox, liposuction, suction-curettage, suction, curettage