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New treatment for tungiasis using a dimeticone of low viscosity

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91405042
Enrollment
45
Registered
2012-01-18
Start date
2012-01-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tungiasis Infections and Infestations Tungiasis [sandflea infestation]

Interventions

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

Sponsors

Institute of Microbiology and Hygiene, Berlin (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026