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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTS-2 DEC patch | Experimental | This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after. |
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| Skin snip | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTS-2 DEC patch | Diagnostic Test | After 24 hours, the patch will be removed, and then the reaction of the skin under the device will be assessed : no reaction, weak reaction (< 50% skin surface under the patch), medium reaction (> 50% skin surface under the patch), and important reaction (reaction on all the surface of the skin under the patch). |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the patch | Proportion of individuals having developed a generalized Mazzotti's reaction | 24 hours |
| Feasibility of the patch | Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis performances | Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips. | 24 hours |
| Loiasis and cross-reactivity assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT) | Yaoundé | Cameroon |
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Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
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Results from LTS-2 patch will be immediately known by both participant and investigators ; but results from skin snips will be masked both for participant and investigators.
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| Skin snips | Diagnostic Test | Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours. |
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Loiasis impact of the diagnosis performances of the LTS-2 DEC patch. Loiasis will be assessed with thick blood smears and a microscopic examination ; and with PCR in the skin snips
| 24 hours |
| Semi-quantitative scoring of the LTS-2 DEC patch results | Relationship between the number of microfilariae of O. volvulus and the skin reaction under the patch (0 no reaction, 1: < 50% of the skin under the patch, 2: >50% of the skin under the patch, and 3: reaction under all the skin surface of the patch) | 24 hours |
| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| D008118 | Loiasis |
| D058069 | Neglected Diseases |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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