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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01274611
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Dec 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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 Names: liposuction
Experimental: Botox	Drug: Botulinum Toxin Type A; Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.; Other Names: botox

Outcome Measures

Primary Outcome Measures

1. Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Alejandra Onate, M.S., Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01274611
• Other Study ID Numbers: STU40780
• First Posted: Jan 11, 2011
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Murad Alam, Professor of Dermatology, Northwestern University: sweating; sweat; underarm; axillary; hyperhidrosis; botox; liposuction; suction-curettage; suction; curettage
• Additional relevant MeSH terms: Hyperhidrosis; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

Recruitment Details	Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.
Pre-assignment Detail	This was a split body, parallel-group randomized control trial with allocation ratio 1:1, using random block size of 2. The unit of randomization was the individual axilla.

Arm/Group Title	Subjects Receiving Split Body Treatment
Arm/Group Description	The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment. Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating. For Suction-Curettage, the doctor inserted 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.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Subjects Receiving Split Body Treatment
Arm/Group Description	The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment. Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating. For Suction-Curettage, the doctor inserted 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.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (8.67)
Sex: Female, Male (Count of Participants)
Female	7 35%
Male	13 65%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Secondary Outcome

Title	The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Botox	Suction-Curettage
Arm/Group Description	Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.	The doctor inserted 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.
Measure Participants	20	20
Measure axillae	20	20
Mean (Standard Deviation) [Scores on a scale]	1.55 (0.68633)	0.08 (0.83351)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Botox, Suction-Curettage
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.80
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
Description	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.
Time Frame	baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Botox	Suction-Curettage
Arm/Group Description	Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.	The doctor inserted 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.
Measure Participants	20	20
Measure axillae	20	20
Mean (Full Range) [Percentage Change]	73.8	58.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Botox, Suction-Curettage
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.
Statistical Test of Hypothesis	p-Value	>0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	15
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	7 months
Arm/Group Title	Botox		Suction-Curettage
Arm/Group Description	Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.		The doctor inserted 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.
All Cause Mortality
	Botox		Suction-Curettage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Botox		Suction-Curettage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Botox		Suction-Curettage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.