Clinical trial NCT01274611: Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
Official title: Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Hyperhidrosis
Keywords: sweating
sweat
underarm
axillary
hyperhidrosis
botox
liposuction
suction-curettage
suction
curettage
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
timeFrame: baseline and 3 months
Secondary outcomes:
measure: The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Alejandra Onate, M.S.
role: PRINCIPAL_INVESTIGATOR
References: