Skip to main content
OpenTrials
Completed

NCT Number: NCT00735293

VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Axillary Hyperhidrosis Body Odor Hyperhidrosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Commons Aesthetic Plastic Surgery

Palo Alto, California, 94306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VASER

Device

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.

Other names: Sound VASER System

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 2 months

  2. To assess patients healing time following VASER treatment of axillary hyperhidrosis

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Commons Aesthetic Plastic Surgery

Other

Collaborators

  • Sound Surgical Technologies, LLC.

Registry information

Official study title

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

Acronym: VASER AxHH

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 14, 2008
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.