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CompletedNCT00735293VASER AxHHUpdated Sep 19, 2008

VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

A Phase 4 interventional study of VASER in Axillary Hyperhidrosis, sponsored by Commons Aesthetic Plastic Surgery. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-19.

Sponsored by Commons Aesthetic Plastic Surgery · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Axillary Hyperhidrosis

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Keywords

  • hyperhidrosis
  • bromidrosis
  • bromhidrosis
  • osmidrosis
  • hircismus
  • excessive
  • underarm
  • sweat
  • perspiration
  • Body Odor
03

In context

Hyperhidrosis

109 studies on the registry are indexed under Hyperhidrosis; 9 are open to participants now.

This study's enrollment of 13 is below the median of 53 across 98 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

This is the only study on the registry with Commons Aesthetic Plastic Surgery as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Other
    Treatment

    There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis

    Device: VASER

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.

    Also known as: Sound VASER System

06

What researchers measure

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

07

Study locations

1 site
  • Commons Aesthetic Plastic Surgery
    Palo Alto, California 94306, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00735293
Lead sponsor
Commons Aesthetic Plastic Surgery
Collaborators
Sound Surgical Technologies, LLC.
First posted
Aug 14, 2008
Start date
Apr 2007
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Sep 19, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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