VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

Commons Aesthetic Plastic Surgery13 enrolled

Overview

Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor

Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Axillary Hyperhidrosis

Interventions

VASERDEVICE

A small incision will be made in the underarm. A VASER probe will be inserted under the skin to break apart fat and sweat glands under the skin. A small hollow tube will be used to draw out the broken-down skin and the incision will be closed with a stitch.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * Willing and able to appear for all scheduled, post-operative visits * Have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment Exclusion Criteria: * under the age of 18 * have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) Skoog procedure, ETS) * have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days * are deemed inappropriate candidates for surgery due to medical or mental health reasons * are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery * elect not to participate in the study

Locations (1)

Commons Aesthetic Plastic Surgery

Palo Alto, California, United States

Outcomes

Primary Outcomes

To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments

Time frame: 6 months

To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment

Time frame: 6 months

Secondary Outcomes

To assess patient's post-operative pain level following VASER using patient self report assessments.

Time frame: 2 months

To assess patients healing time following VASER treatment of axillary hyperhidrosis

Time frame: 6 months

To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER

Time frame: 6 months

Data from ClinicalTrials.gov

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