LymphedemaNCT00139100
Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
A study testing antimicrobial agent in soap in people with Lymphedema and Cellulitis, run by Centers for Disease Control and Prevention at 1 site in Haiti.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphedema, Cellulitis
- What is being tested?
- antimicrobial agent in soap
- How many people
- 200 participants
- Where
- 1 siteHaiti
- Study dates
- Feb 2001to Mar 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
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
- Lymphedema, Cellulitis
- Being tested
- antimicrobial agent in soap
- Medical subject headings
- Lymphedema, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial agent in soapDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bacterial "acute attacks", assessed monthly.
Reported or observed severity of these acute attacks.
Duration of acute attacks.
Secondary outcomes (5)
Process measures
Number of bars of soap used per patient per month.
Demonstrated knowledge and ability to wash leg appropriately during home visits.
Reported patient satisfaction with soap.
Reported frequency of leg washing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startFeb 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Procter and Gamble, Ste. Croix Hospital, Leogane, Haiti
- Investigators
- David G Addiss, MD, Principal investigator, CDC/NCID/DPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139100
- Sponsor's protocol ID
- CDC-NCID-2822
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2005
- Last updated
- 24 Oct 2008
- Results posted
- No
Publications
Addiss DG, Michel MC, Michelus A, Radday J, Billhimer W, Louis-Charles J, Roberts JM, Kramp K, Dahl BA, Keswick B. Evaluation of antibacterial soap in the management of lymphoedema in Leogane, Haiti. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):58-60. doi: 10.1016/j.trstmh.2010.08.011. Epub 2010 Sep 17.
PubMed 20850849
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
- ClinicalTrials.gov ID
- NCT00139100
- Acronym / sponsor ID
- CDC-NCID-2822
- Conditions
- Lymphedema, Cellulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Procter and Gamble, Ste. Croix Hospital, Leogane, Haiti
- Study start
- Feb 2001
- Study completion
- Mar 2002
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimicrobial agent in soap | Drug | – |
Primary outcome
Incidence of bacterial "acute attacks", assessed monthly.
Reported or observed severity of these acute attacks.
Duration of acute attacks.
5 secondary outcomes
Process measures
Number of bars of soap used per patient per month.
Demonstrated knowledge and ability to wash leg appropriately during home visits.
Reported patient satisfaction with soap.
Reported frequency of leg washing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
- Derived from this study: PubMed 20850849Addiss DG, Michel MC, Michelus A, Radday J, Billhimer W, Louis-Charles J, Roberts JM, Kramp K, Dahl BA, Keswick B. Evaluation of antibacterial soap in the management of lymphoedema in Leogane, Haiti. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):58-60. doi: 10.1016/j.trstmh.2010.08.011. Epub 2010 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Addiss, MD principal investigator
CDC/NCID/DPD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antimicrobial agent in soap in people with Lymphedema and Cellulitis, run by Centers for Disease Control and Prevention at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacterial "acute attacks", assessed monthly.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.