Plain English Summary
Background and study aims
Tungiasis is a parasitic skin disease caused by the sand flea. It occurs in economically deprived communities such as in Madagascar. It is associated with considerable illness, such as chronic lymphoedema (swelling), ulcers, fissures, nail loss, difficulty in walking and gripping and infection. The only efficient measure against is surgical extraction with generally non sterile material causing further illness. The aim of this study is to test preventive measures to reduce tungiasis-related illness.
Who can participate?
Patients aged 5 and over with tungiasis
What does the study involve?
Participants are randomly allocated to one of three groups. In the first group Zanzarin (an insect repellent) is applied twice daily on the feet and ankles for 3 months, in the second group participants receive sport shoes, and the third group receive no treatment. The number of tungiasis lesions are counted every two weeks during the 3-month study. At the end of the study after 3 months all participants receive sport shoes, and if there are remaining tungiasis lesions these are extracted at the local health center, and local antibiotics and tetanus vaccinations are given.
What are the possible benefits and risks of participating?
Not provided at time of registration
When is the study starting and how long is it expected to run for?
August to October 2011
Where is the study run from?
Villages in the area of Andasibé in Moramanga district in Madagascar
Who is funding the study?
Doctors for the Third World (Ärzte für die dritte Welt) (Germany)
Who is the main contact?
Prof. Hermann Feldmeier
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Morbidity prevention of tunga penetrans in a resource-poor community in Madagascar: a randomized controlled trial
Acronym
Study hypothesis
The regular application of Zanzarin®, a coconut oil-based plant repellent, protects against morbidity associated with Tunga penetrans. The trial will evaluate the effacacy Zanzarin® compared to the wearing of shoes.
Ethics approval
Ethics Committee of the Health Ministry of Madagascar, 05/05/2011
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Tungiasis
Intervention
Three cohort groups:
1. Zanzarin® ( active ingredients: capric acid, cocos nucifera, citronellol) : topical application 5 ml twice daily on the feet and ankles for 3 months
2. Wearing sports shoes
3. Control group, no intervention
Intervention type
Drug
Phase
Not Applicable
Drug names
Zanzarin®
Primary outcome measure
To assess the impact of the different interventions the following outcome measures will be compared every two weeks during three month. Lesion stage will be assessed according the Fortaleza Classification.
1. Total number of lesions located at the feet
2. Number of viable lesions (stage 1-3)
3. Number of non-viable lesions (stage 4)
4. Ratio of viable lesions (stage 1 to 3) divided by total number of lesions
5. Ratio of non-viable lesions (stage 4) divided by total number of lesions
6. Percentage of participants without viable lesions at the end of the study
7. Severity score for acute and chronic tungiasis-associated morbidity
To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.
Secondary outcome measures
To assess the impact of the different interventions the following outcome measures will be compared:
1. Percentage of participants without viable lesions at the end of the study
2. Modified severity score for acute and chronic tungiasis-associated morbidity
To assess the impact of the different interventions the outcome measures will be compared every two weeks during three months. Lesion stage will be assessed according the Fortaleza Classification.
Overall trial start date
01/08/2011
Overall trial end date
30/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. More than or equal to 10 tungiasis lesions
2. Aged more than or equal to 5 years
3. 4-5 days of permanence in the village per week
4. Permanence in the village during next 4 months
5. The participants or their legal guardian have signed the informed written consent
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
225
Participant exclusion criteria
1. Less than or equal to 10 tungiasis lesions
2. Aged less than 5 years
3. Less than 4-5 days of permanence in the village per week
4. Less than 4 months permanence in the village
5. The participants or their legal guardian have not signed the informed written consent
Recruitment start date
01/08/2011
Recruitment end date
30/10/2011
Locations
Countries of recruitment
Madagascar
Trial participating centre
am Rain 7
Buchholz in Nordheide
21244
Germany
Sponsor information
Organisation
Doctors for the Third World [Ärzte für die dritte Welt] (Germany)
Sponsor details
Offenbacher Landstraße 224
60599 Frankfurt am Main
Frankfurt am Main
60599
Germany
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Doctors for the Third World [Ärzte für die dritte Welt] (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list