VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00735293

Acronym

VASER AxHH

Enrollment

Registered

2008-08-14

Start date

2007-04-30

Completion date

2008-08-31

Last updated

2008-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Hyperhidrosis

Keywords

hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat, perspiration, Body Odor

Brief summary

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

Detailed description

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.

Interventions

DEVICEVASER

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments	6 months
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment	6 months

Secondary

Measure	Time frame
To assess patient's post-operative pain level following VASER using patient self report assessments.	2 months
To assess patients healing time following VASER treatment of axillary hyperhidrosis	6 months
To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026