Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa (EOLoa)

Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Status: Withdrawn

Conditions: Loiasis; Neglected Diseases; Diagnoses Disease; Onchocerciasis

Treatments: Diagnostic Test: Skin snips; Diagnostic Test: LTS-2 DEC patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04035174

C18-56

Details and patient eligibility

About

This study aims at evaluating the diagnosis performances of the LTS-2 DEC patch for onchocerciasis compared to the gold standard which are the skin snips. This study will be conducted in Cameroon in two different areas : Ngog-Mapubi and Bafia Health Districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All voluntary adults

Exclusion criteria

• General acute infection (temperature ≥ 38,5°C)
• Impaired general condition
• Ivermectin taken in the 6 last months
• Known allergies to one of the component of the patch
• Dermatological acute infection (bacterial, atopic, prurigo, or zona)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups

LTS-2 DEC patch

Experimental group

Description:

This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after.

Treatment:

Diagnostic Test: LTS-2 DEC patch

Diagnostic Test: Skin snips

Skin snip

Active Comparator group

Description:

A skin snip will be performed using a 2 mm Holth corneoscleral's punch. Once done, the microfilariae of Onchocerca volvulus will be counted with a microscope.

Treatment:

Diagnostic Test: LTS-2 DEC patch

Diagnostic Test: Skin snips