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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01274611
First received: January 10, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

January 10, 2011
January 15, 2013
December 2010
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01274611 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Axillary Hyperhidrosis
  • Drug: Botulinum Toxin Type A
    Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
    Other Name: botox
  • Device: 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
  • Active Comparator: Suction-Curettage
    Intervention: Device: Suction-Curettage
  • Experimental: Botox
    Intervention: Drug: Botulinum Toxin Type A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01274611
STU40780
Yes
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP