Condition category
Infections and Infestations
Date applied
13/07/2011
Date assigned
28/09/2011
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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, 5 May 2011

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below 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 following outcome measures will be compared every two weeks during three month. 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 following outcome measures will be compared every two weeks during three month. 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

Child

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

Government

Website

http://www.aerzte3welt.de/

Funders

Funder type

Government

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