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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnoses Disease; Onchocerciasis; Neglected Diseases; Loiasis
• Intervention / Treatment: Diagnostic test: LTS-2 DEC patch; Diagnostic test: Skin snips

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guy Sadeu Wafeu, MD; Phone Number: +237676041565; Email: wafeuguy@gmail.com
• Study Contact Backup: Name: Cédric B Chesnais, MD; Phone Number: +33467416162; Email: cedric.chesnais@ird.fr

Study Locations

• Cameroon
  • Yaoundé, Cameroon
    • Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
    • Contact: Guy Sadeu Wafeu, MD; Phone Number: +237676041565; Email: wafeuguy@gmail.com
    • Contact: Joseph Kamgno, MD; Phone Number: 237222202442; Email: kamgno@crfilmt.org
    • Principal Investigator: Joseph Kamgno, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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).; Diagnostic test: Skin snips; Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Active Comparator: 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.	Diagnostic test: 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).; Diagnostic test: Skin snips; Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Health Public
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Disease Attributes; Parasitic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Filariasis; Disease; Onchocerciasis; Neglected Diseases
• Other Study ID Numbers: C18-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No