Condition category
Infections and Infestations
Date applied
29/01/2014
Date assigned
18/02/2014
Last edited
18/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and summary
Tungiasis (sand flea disease) is a neglected tropical parasitic disease. It occurs in many countries in South America and sub-Saharan Africa and effects the poorest of the poor. 99% of the parasites penetrate into the skin of the feet. Parts of the body which are particularly affected are the toes, the sole, the lateral rim and the heel. In the endemic areas, prevalences are up to 70% in children and 30% in the general population.
Sand fleas burrowed in the skin elicit an intense inflammatory response. Acute and chronic inflammation results in fissures, ulcers, pain and difficulty walking. Repeated infections are debilitating and eventually lead to mutilation of the toes.
In a previous study it was shown that wetting the skin of the feet three times within 10 minutes with a combination of two dimeticones with a very low viscosity killed 78% of the parasite.
It is assumed that a repeated targeted application of dimeticone to the site where parasites are burrowed in the skin will increase the efficacy of the treatment to ≥ 95%. Since the application of dimeticone can be performed with minimal input from the health sector, this treatment will become the core measure in national control programs against tungiasis currently being developed by the Ministries of Health in several East African countries. The study will be performed in Busoga Region, Uganda, north of Lake Victoria, an area which is notoriously affected by tungiasis.

Who can participate?
55 school children between 6 and 15 years with tungiasis will be admitted to the study.

Who does the study involve?
Every day, 3 - 4 school children are admitted to the study and are followed up daily during 7 days. (on the basis of having at least two viable parasites on each foot). The left and the right foot of each participant are randomly allocated to one of two treatments: either the standard treatment (wetting the foot with dimeticone 3 times during 10 minutes) or the targeted treatment (application of the dimeticone directly on the abdominal cone of the parasite which protrudes through the skin with the help of a syringe). At the end of the study, the following are compared between left and right feet:
- % of viable parasites that died after the application of dimeticone
- % of parasites that did not develop in a normal manner
- regression of the intensity of local inflammation

What are the possible benefits and risks of participating?
A direct benefit for the participants is that they are relieved from a parasitic skin disease for which there is currently no effective treatment. As dimeticones are wholly non-toxic, the treatment does not pose any health risk.

Where is the study run from?
The study has been set up by the Institute of Microbiology and Hygiene of the Charité University Medicine, Berlin, Germany, together with the Ministry of Health, Kampala, Uganda. It will take place in Bugiri, Busoga region, Uganda.

When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start at the beginning of March 2014 and is expected to end on April 30, 2014.

Who is funding the study?
The study is funded by German Doctors e.V., a non-governmental organization as well as by private donations.

Who is the main contact?
Prof. Hermann Feldmeier
hermann.feldmeier@charite.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hermann Feldmeier

ORCID ID

Contact details

Hindenburgdamm 27
Berlin
12203
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Dimeticone II

Study information

Scientific title

Treatment of TUNGiasis (jiggers) with a targeted Application of a two-component DIMETicone

Acronym

TUNGADIMET

Study hypothesis

It is assumed that a repeated targeted application of dimeticone to the site where parasites are burrowed in the skin has a higher efficacy in killing embedded sand fleas than simply wetting the skin of the feet with dimeticone (the standard procedure).

Ethics approval

Ethics Committee, the Ministry of Health, Kampala, Uganda, January 29, 2013

Study design

Randomized trial using the left and the right foot of the participants as units of randomization.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tungiasis (sand flea disease), a neglected tropical disease

Intervention

The left and the right foot of each participant are randomized to either receive the standard treatment (wetting the foot with dimeticone 3 times during 10 minutes) or the targeted treatment: application of the dimeticone directly on the abdominal cone of the parasite (which protrudes through the skin) with the help of a syringe.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dimeticone

Primary outcome measures

1. % of viable parasites that died after the application of dimeticone. Viability is determined with a portable digital video microscope.
2. % of parasites that did not develop in a normal manner

Followed up daily during 7 days

Secondary outcome measures

Regression of the intensity of local inflammation

Overall trial start date

01/03/2014

Overall trial end date

30/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. School children between 6 and 15 years with at least two viable sand fleas in the skin of each foot.
2. Care-takers are requested to sign an informed written consent form for the participant before admission.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

55

Participant exclusion criteria

Children with severe bacterial superinfection of tungiasis lesions are not eligible and will be referred to the next primary health care center for antibiotic treatment.

Recruitment start date

01/03/2014

Recruitment end date

30/04/2014

Locations

Countries of recruitment

Uganda

Trial participating centre

Hindenburgdamm 27
Berlin
12203
Germany

Sponsor information

Organisation

German Doctors e.V. (Germany)

Sponsor details

Löbestraße 1a
Bonn
53173
Germany

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

German Doctors e.V., a non-governmental organization (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