NCT00228072

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

First QC Date

September 26, 2005

Last Update Submit

May 28, 2008

Conditions

Hyperhidrosis

Keywords

HyperhidrosisAxillaryExcisionSuction-curettageOutcome

Interventions

Suction-curettagePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult individuals with primary axillary hyperhidrosis

You may not qualify if:

  • Secondary axillary hyperhidrosis
  • Hidrosadenitis axillaris/inguinalis
  • Prior surgery
  • Iontophoresis or botox treatment 12 months prior
  • Known hypersensitivity to local analgetics (lidocaine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic Surgery, Odense University Hospital

Odense, Fyn, DK-5000, Denmark

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Vacuum Curettage

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dilatation and CurettageCurettageSurgical Procedures, OperativeGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Finn Gottrup, DMsci

    University Center of Wound Healing, Dept. of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark

    STUDY CHAIR

  • Torben Moeller-Christensen, MD

    Department of Plastic Surgery, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Primary Completion

February 1, 2008

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

DK(1)