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

NCT ID: NCT01274611

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Axillary Hyperhidrosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suction-Curettage

Group Type ACTIVE_COMPARATOR

Suction-Curettage

Intervention Type 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.

Botox

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

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

Interventions

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Botulinum Toxin Type A

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

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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botox liposuction

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandra Onate, M.S.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU40780

Identifier Type: -

Identifier Source: org_study_id