New treatment for tungiasis using a dimeticone of low viscosity
| ISRCTN | ISRCTN91405042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91405042 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/12/2011
- Registration date
- 18/01/2012
- Last edited
- 05/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Institute of Microbiology and Hygiene
Campus Benjamin Franklin
Charité - Medical University Berlin
Hindenburgdamm 27
Berlin
12203
Germany
Study information
| Study design | Clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | New treatment for tungiasis using a dimeticone of low viscosity, in a resource-poor community in Kenya: a proof of principle study |
| Study objectives | 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(s) | Ministry of Medical Services Ethics Committee, Kenya, 20/12/2011, ref: NMS/ADM/3/8/VOL.111 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/01/2012 |
| Completion date | 28/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/01/2012 |
| Date of final enrolment | 28/02/2012 |
Locations
Countries of recruitment
- Germany
- Kenya
Study participating centre
12203
Germany
Sponsor information
Research organisation
Hindenburgdamm 27
Berlin
12203
Germany
| Website | http://www.charite.de/imh/ |
|---|---|
"ROR" |
https://ror.org/04xqmb911 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
