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VASER Treatment of Axillary Hyperhidrosis/Bromidrosis (VASER AxHH)

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ClinicalTrials.gov Identifier: NCT00735293
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : September 19, 2008
Sound Surgical Technologies, LLC.
Information provided by:
Commons Aesthetic Plastic Surgery

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

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Device: VASER Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
Study Start Date : April 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis
Device: VASER
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 Name: Sound VASER System

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735293

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United States, California
Commons Aesthetic Plastic Surgery
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Commons Aesthetic Plastic Surgery
Sound Surgical Technologies, LLC.
Additional Information:
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Responsible Party: George W. Commons, M.D., Commons Aesthetic Plastic Surgery
ClinicalTrials.gov Identifier: NCT00735293    
Other Study ID Numbers: VASER AxHH
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Keywords provided by Commons Aesthetic Plastic Surgery:
Body Odor
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases