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: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention
Axillary Hyperhidrosis
Drug: Botulinum Toxin Type A
Device: Suction-Curettage

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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...

    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.



Enrollment: 20
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274611

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01274611     History of Changes
Other Study ID Numbers: STU40780
Study First Received: January 10, 2011
Results First Received: July 18, 2013
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
sweating
sweat
underarm
axillary
hyperhidrosis
botox
liposuction
suction-curettage
suction
curettage

Additional relevant MeSH terms:
Hyperhidrosis
Skin Diseases
Sweat Gland Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014