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Completed

NCT Number: NCT01274611

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.

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Key information

Conditions

Axillary Hyperhidrosis Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.

Other names: botox

Suction-Curettage

Device

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 names: liposuction

Primary outcomes

  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 outcomes

  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...

    • never noticeable and never interferes with my daily activities
    • tolerable but sometimes interferes with my daily activities
    • barely tolerable and frequently interferes with my daily activities
    • 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2011
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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