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

• Sponsor: Center for Research on Filariasis and Other Tropical Diseases, Cameroon (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04035174
• Collaborator: (none)
• Enrollment: 1,400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 202.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Onchocerciasis; Loiasis; Diagnoses Disease; Neglected Diseases	Diagnostic Test: LTS-2 DEC patch; Diagnostic Test: Skin snips	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1400 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
• Masking: Single (Outcomes Assessor)
• Masking Description: Results from LTS-2 patch will be immediately known by both participant and investigators ; but results from skin snips will be masked both for participant and investigators.
• Primary Purpose: Diagnostic
• Official Title: Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Tolerability of the patch [24 hours]

   Proportion of individuals having developed a generalized Mazzotti's reaction

2. Feasibility of the patch [24 hours]

   Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.

Secondary Outcome Measures

1. 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.

2. 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

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)	Yaoundé		Cameroon

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
• ClinicalTrials.gov Identifier: NCT04035174
• Other Study ID Numbers: C18-56
• First Posted: Jul 29, 2019
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Center for Research on Filariasis and Other Tropical Diseases, Cameroon: Health Public
• Additional relevant MeSH terms: Onchocerciasis; Disease; Neglected Diseases

Study Results

No Results Posted as of Dec 9, 2021