Condition category
Infections and Infestations
Date applied
19/12/2011
Date assigned
18/01/2012
Last edited
05/09/2014
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 Tunga penetrans. In tropical countries tungiasis is associated with symptoms such as lymphoedema (swelling), ulcers, fissures, nail loss, difficulty in walking and bacterial infection. The only efficient treatment is surgical extraction. However, in endemic areas, non-sterile instruments are usually used, which causes more harm than good. The aim of this study is to evaluate a new treatment consisting of the local application of dimeticone to the skin of the feet.

Who can participate?
Children aged five years old and over who have at least two viable lesions on each foot.

What does the study involve?
The feet of each study participant will be randomly allocated to either to dimeticone or to potassium permanganate, the standard treatment of the Ministry of Health of Kenya. The applications will be repeated on three subsequent days. The lesions will be monitored daily for parasites for a total of seven days. At the end of the study, participants will receive a pair of shoes and all pupils of the school who are infected with Tunga penetrans will receive the treatment identified as the most effective.

What are the possible benefits and risks of participating?
Adverse effects of dimeticone are not known.

Where is the study run from?
From two schools in the Gatundu district, Kenya.

When is the study starting and how long is it expected to run for?
From January to February 2012.

Who is funding the study?
The trial is funded by the Institute of Microbiology and Hygiene, Berlin, Germany.

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hermann Feldmeier

ORCID ID

Contact details

Institute of Microbiology and Hygiene
Campus Benjamin Franklin
Charité - Medical University Berlin
Hindenburgdamm 27
Berlin
12203
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

New treatment for tungiasis using a dimeticone of low viscosity, in a resource-poor community in Kenya: a proof of principle study

Acronym

Study hypothesis

Dimeticone, a silicone oil of extremely low viscosity, has an insecticidal impact on Tunga penetrans as soon as a sand flea has penetrated into the skin. Since clinical pathology is associated with the natural development of the parasite, a second hypothesis is that the application of dimeticone prevents clinical pathology to develop.

Ethics approval

Ministry of Medical Services Ethics Committee, Kenya, 20/12/2011, ref: NMS/ADM/3/8/VOL.111

Study design

Clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

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

Intervention

Application of dimeticone or potassium permanganate on the right or left foot, respectively, for 5 minutes. Then the feet will be kept in an upright position to allow the solutions to dry. Shoes will be used thereafter as normal. The applications will be repeated on three subsequent days.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Assess the impact of the different interventions the following outcome measure will be compared every day during a period of 7 days
2. Lesions stage will be assessed according the Fortaleza Classification
3. Number of embedded sand fleas on each foot which loses viability signs and/or for which normal development is interrupted in relation to the number of lesions with a normal development

Secondary outcome measures

The intensity of inflammation of the left and right foot assessed semi-quantitatively using a previously established severity score (SSAT)

Overall trial start date

09/01/2012

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ages 5 - 16 years
2. Presence of at least 2 lesions in stage IIa or IIIa (Fortaleza Classification)
3. Presence of at least 2 out of 3 viability signs:
3.1. Expulsion of eggs
3.2. Excretion of faeces
3.3. Characteristic pulsations in the abdomen of the parasite
4. Informed written consent, in the case of children by the caregiver

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Presence of gross inflammation on either foot
2. Presence of abscess/suppuration on either foot
3. Presence of ascending lymphangitis on either foot

Recruitment start date

09/01/2012

Recruitment end date

28/02/2012

Locations

Countries of recruitment

Kenya

Trial participating centre

Institute of Microbiology and Hygiene
Berlin
12203
Germany

Sponsor information

Organisation

Institute of Microbiology and Hygiene, Berlin (Germany)

Sponsor details

Hindenburgdamm 27
Berlin
12203
Germany

Sponsor type

Research organisation

Website

http://www.charite.de/imh/

Funders

Funder type

Research organisation

Funder name

Institute of Microbiology and Hygiene, Berlin (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