Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
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.
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|
- Measurement of Sweat Production using Gravimetry [ Time Frame: 10-12 weeks ] [ Designated as safety issue: No ]The primary outcome measure will be the reduction of sweat production in mg per min in both the resting state and the exercise-induced state.
- Subject Satisfaction Using Disease Severity Scale [ Time Frame: 10-12 weeks, and 22-24 weeks ] [ Designated as safety issue: No ]The secondary outcome measure will be the reduction in mean score on the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is a widely accepted, subjective questionnaire that assigns a point value to the patient's view and tolerance of their disease.
|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
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|