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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01539460
Other study ID # TDH0369
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 21, 2012
Last updated May 11, 2017
Start date February 2012
Est. completion date December 2017

Study information

Verified date May 2017
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.


Description:

Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 18 years or older

- unpleasant odor from the axillae

- Willing and able to appear for all scheduled, post-operative visits

Exclusion Criteria:

- under the age of 18

- have undergone a prior surgical intervention

- inappropriate candidates for surgery due to medical or mental health reasons

- elect not to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
minimally invasive surgery
Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.

Locations

Country Name City State
China Yuejun Li Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments the satisfaction of patients up to 24 months
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