Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
NCT ID: NCT04035174
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-09-01
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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LTS-2 DEC patch
This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after.
LTS-2 DEC patch
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).
Skin snips
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Skin snip
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.
LTS-2 DEC patch
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).
Skin snips
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Interventions
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LTS-2 DEC patch
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).
Skin snips
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Center for Research on Filariasis and Other Tropical Diseases, Cameroon
OTHER
Responsible Party
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Locations
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Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Yaoundé, , Cameroon
Countries
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Other Identifiers
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C18-56
Identifier Type: -
Identifier Source: org_study_id
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