Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
Drug: Botulinum Toxin Type A
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis|
- Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
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.
- The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
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.
|Study Start Date:||December 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Suction-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.
Other Name: liposuction
Drug: Botulinum Toxin Type A
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
Other Name: botox
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274611
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|