Liposuction as Treatment for Excessive Axillary Sweat

Hyperhidrosis Clinical Trial

Official title:

Suction-Curettage vs. Standard Excision in Axillary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228072
• Other study ID #: VF20030189
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2005
• Last updated: May 28, 2008

Study information

• Verified date: May 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if suction-curettage of the axilla is favorable in regard to effect, recovery and cosmetic appearance compared to standard surgical excision of the skin of the axilla in case of excessive sweating.

Description:

The surgical standard treatment for isolated excessive axillary sweating is excision of the hair-bearing area of the axilla. This technique is associated with a risk of impaired wound healing, infections, wide scars and a risk of impairment in the movement of the arm (seldom).

A new technique suction-curettage, much alike the liposuction technique, in which the dermis is curettage from a sub-dermal approach with a cutting and sucking devise, may be promising in regard to recovery and cosmetic appearance postoperatively, but the effect of the sweat production is not well known. This study compares liposuction vs. standard excision in individuals with isolated excessive isolated axillary sweating randomized to treatment with one of each technique in both axillas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult individuals with primary axillary hyperhidrosis

Exclusion Criteria:

• Secondary axillary hyperhidrosis

• Hidrosadenitis axillaris/inguinalis

• Prior surgery

• Iontophoresis or botox treatment 12 months prior

• Known hypersensitivity to local analgetics (lidocaine)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Procedure:
• Suction-curettage

Locations

Country	Name	City	State
Denmark	Department of Plastic Surgery, Odense University Hospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark,