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

NCT01274611 | Completed Results DMC

• 1 other identifier: STU40780
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Axillary Hyperhidrosis

Keywords

sweating; sweat; underarm; axillary; hyperhidrosis; botox; liposuction; suction-curettage; suction; curettage

Outcome Measures

Primary Outcomes (1)

• Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 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.

  baseline and 3 months

Secondary Outcomes (1)

• The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment

  Baseline and 3 months

Study Arms (2)

Suction-Curettage

ACTIVE COMPARATOR

Device: Suction-Curettage

Botox

EXPERIMENTAL

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

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

Also known as: botox

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.

Also known as: liposuction

Suction-Curettage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A; Vacuum Curettage; Lipectomy

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Plastic Surgery Procedures

Limitations and Caveats

There was a the lack of long-term assessment of comparative effectiveness. It is uncertain whether suction-curettage removes the eccrine sweat glands or mainly the apocrine glands.

Results Point of Contact

• Title: Dr. Murad Alam
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Alejandra Onate, M.S.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 6, 2021
• Results First Posted: February 3, 2014

Record last verified: 2021-12

Locations

US (1)