Condition category
Infections and Infestations
Date applied
13/07/2011
Date assigned
28/09/2011
Last edited
19/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Hermann Feldmeier

ORCID ID

Contact details

am Rain 7
Buchholz in Nordheide
21244
Germany

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 measures

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

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

http://www.aerzte3welt.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/04/2017: Plain English summary added.