An interventional study of LTS-2 DEC patch and Skin snips in Onchocerciasis, Loiasis and Diagnoses Disease, sponsored by Center for Research on Filariasis and Other Tropical Diseases, Cameroon. Withdrawn at 1 site in Cameroon. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Center for Research on Filariasis and Other Tropical Diseases, Cameroon · Not applicable, Interventional, and Diagnostic
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).
35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.
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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 · Diagnostic Test: Skin snips
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 · Diagnostic Test: Skin snips
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).
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Tolerability of the patch
Proportion of individuals having developed a generalized Mazzotti's reaction
Time frame: 24 hours
Feasibility of the patch
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Time frame: 24 hours
Diagnosis performances
Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.
Time frame: 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
Time frame: 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)
Time frame: 24 hours
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for Oct 2022, 1 month later.
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This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Center for Research on Filariasis and Other Tropical Diseases, Cameroon