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

Not Applicable

Withdrawn

• Conditions: Onchocerciasis; Diagnoses Disease; Loiasis; Neglected Diseases
• Interventions: Diagnostic Test: LTS-2 DEC patch; Diagnostic Test: Skin snips

• Registration Number: NCT04035174
• Lead Sponsor: Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2022-09-01
• Primary Completion: 2022-10-30
• Study Completion: 2023-03-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 1400

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin snip	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.
LTS-2 DEC patch	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	Skin snips	This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after.
Skin snip	LTS-2 DEC patch	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the patch	24 hours	Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Tolerability of the patch	24 hours	Proportion of individuals having developed a generalized Mazzotti's reaction

Secondary Outcome Measures

Name	Time	Method
Diagnosis performances	24 hours	Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.
Loiasis and cross-reactivity assessment	24 hours	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
Semi-quantitative scoring of the LTS-2 DEC patch results	24 hours	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)

Trial Locations

Locations (1)

Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT); 🇨🇲 Yaoundé, Cameroon