Clinical Trials Directory

Trials / Completed

CompletedNCT00139100

Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area

Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (planned)
Sponsor
Centers for Disease Control and Prevention · Federal
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being. Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.

Conditions

Interventions

TypeNameDescription
DRUGantimicrobial agent in soap

Timeline

Start date
2001-02-01
Completion
2002-03-01
First posted
2005-08-31
Last updated
2008-10-24

Locations

1 site across 1 country: Haiti

Source: ClinicalTrials.gov record NCT00139100. Inclusion in this directory is not an endorsement.