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

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ClinicalTrials.gov Identifier: NCT01274611
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : February 3, 2014
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Drug: Botulinum Toxin Type A Device: Suction-Curettage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis
Study Start Date : December 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Suction-Curettage 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
Experimental: Botox Drug: Botulinum Toxin Type A
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
Other Name: botox


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months [ Time Frame: baseline and 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.



Secondary Outcome Measures :
  1. The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment [ Time Frame: Baseline and 3 months ]

    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...

    1. never noticeable and never interferes with my daily activities
    2. tolerable but sometimes interferes with my daily activities
    3. barely tolerable and frequently interferes with my daily activities
    4. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274611


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Alejandra Onate, M.S. Northwestern University
More Information
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Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01274611    
Other Study ID Numbers: STU40780
First Posted: January 11, 2011    Key Record Dates
Results First Posted: February 3, 2014
Last Update Posted: December 6, 2021
Last Verified: December 2021
Keywords provided by Murad Alam, Northwestern University:
sweating
sweat
underarm
axillary
hyperhidrosis
 botox
liposuction
suction-curettage
suction
curettage
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents