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

NCT04035174 | Withdrawn DMC

• 1 other identifier: C18-56
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Onchocerciasis; Loiasis; Diagnoses Disease; Neglected Diseases

Keywords

Health Public

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Diagnosis performances

  24 hours

• Loiasis and cross-reactivity assessment

  24 hours

• Semi-quantitative scoring of the LTS-2 DEC patch results

  24 hours

Study Arms (2)

LTS-2 DEC patch

EXPERIMENTAL

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

Skin snip

ACTIVE COMPARATOR

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

Interventions

LTS-2 DEC patch DIAGNOSTIC_TEST

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).

LTS-2 DEC patch; Skin snip

Skin snips DIAGNOSTIC_TEST

Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.

LTS-2 DEC patch; Skin snip

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All voluntary adults

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Onchocerciasis; Loiasis; Neglected Diseases

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: September 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: March 30, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)