Working… Menu
Trial record 1 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139100
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : October 24, 2008
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Information provided by:
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Lymphedema Cellulitis Drug: antimicrobial agent in soap Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
Study Start Date : February 2001
Study Completion Date : March 2002

Primary Outcome Measures :
  1. Incidence of bacterial "acute attacks", assessed monthly.
  2. Reported or observed severity of these acute attacks.
  3. Duration of acute attacks.

Secondary Outcome Measures :
  1. Process measures
  2. Number of bars of soap used per patient per month.
  3. Demonstrated knowledge and ability to wash leg appropriately during home visits.
  4. Reported patient satisfaction with soap.
  5. Reported frequency of leg washing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene).


Exclusion Criteria: Don't meet inclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139100

Layout table for location information
Hopital Ste. Croix
Leogane, Haiti
Sponsors and Collaborators
Centers for Disease Control and Prevention
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Layout table for investigator information
Principal Investigator: David G Addiss, MD CDC/NCID/DPD

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00139100     History of Changes
Other Study ID Numbers: CDC-NCID-2822
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: August 2005
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Infective Agents
Lymphatic Diseases
Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Anti-Bacterial Agents