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

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa

Conditions
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Onchocerciasis, Loiasis, Diagnoses Disease, Neglected Diseases

Intervention / Treatment
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* Diagnostic Test: LTS-2 DEC patch
* Diagnostic Test: Skin snips


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTS-2 DEC patch<br>This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after. | Diagnostic Test: LTS-2 DEC patch<br>* 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).<br>Diagnostic Test: Skin snips<br>* Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.<br>|
| Active Comparator: Skin snip<br>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. | Diagnostic Test: LTS-2 DEC patch<br>* 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).<br>Diagnostic Test: Skin snips<br>* Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Public