Back to resultsEvaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa (EOLoa)
Primary Purpose
Onchocerciasis, Loiasis, Diagnoses Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
LTS-2 DEC patch
Skin snips
Sponsored by
About this trial
This is an interventional diagnostic trial for Onchocerciasis focused on measuring Health Public
Eligibility Criteria
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)
Sites / Locations
- Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LTS-2 DEC patch
Skin snip
Arm Description
This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after.
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.
Outcomes
Primary Outcome Measures
Tolerability of the patch
Proportion of individuals having developed a generalized Mazzotti's reaction
Feasibility of the patch
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Secondary Outcome Measures
Diagnosis performances
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
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
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)
Full Information
NCT ID
NCT04035174
First Posted
July 25, 2019
Last Updated
November 25, 2021
Sponsor
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
1. Study Identification
Unique Protocol Identification Number
NCT04035174
Brief Title
Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
Acronym
EOLoa
Official Title
Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis, Loiasis, Diagnoses Disease, Neglected Diseases
Keywords
Health Public
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
Masking
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.
Allocation
Non-Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTS-2 DEC patch
Arm Type
Experimental
Arm Description
This is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after.
Arm Title
Skin snip
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
LTS-2 DEC patch
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin snips
Intervention Description
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Primary Outcome Measure Information:
Title
Tolerability of the patch
Description
Proportion of individuals having developed a generalized Mazzotti's reaction
Time Frame
24 hours
Title
Feasibility of the patch
Description
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Diagnosis performances
Description
Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.
Time Frame
24 hours
Title
Loiasis and cross-reactivity assessment
Description
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
Time Frame
24 hours
Title
Semi-quantitative scoring of the LTS-2 DEC patch results
Description
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)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric B Chesnais, MD
Phone
+33467416162
Email
cedric.chesnais@ird.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Sadeu Wafeu, MD
Phone
+237676041565
Email
wafeuguy@gmail.com
Facility Information:
Facility Name
Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)
City
Yaoundé
Country
Cameroon
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Sadeu Wafeu, MD
Phone
+237676041565
Email
wafeuguy@gmail.com
First Name & Middle Initial & Last Name & Degree
Joseph Kamgno, MD
Phone
237222202442
Email
kamgno@crfilmt.org
First Name & Middle Initial & Last Name & Degree
Joseph Kamgno, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
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