Viewing Study NCT00139100



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Study NCT ID: NCT00139100
Status: COMPLETED
Last Update Posted: 2008-10-24
First Post: 2005-08-29

Brief Title: Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
Status: COMPLETED
Status Verified Date: 2005-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None