OnchocerciasisEOLoaNCT04035174
Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
A study testing LTS-2 DEC patch and Skin snips in people with Onchocerciasis and Loiasis, run by Center for Research on Filariasis and Other Tropical Diseases, Cameroon at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Onchocerciasis, Loiasis, Diagnoses Disease
- What is being tested?
- LTS-2 DEC patch and Skin snips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Sep 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All voluntary adults
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Yaoundé
About this study
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
- Being tested
- LTS-2 DEC patch, Skin snips
- Keywords
- Health Public
- Medical subject headings
- Onchocerciasis, Loiasis, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTS-2 DEC patchDiagnostic 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).
Skin snipsDiagnostic test
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: LTS-2 DEC patch; Diagnostic Test: Skin snips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the patch
Proportion of individuals having developed a generalized Mazzotti's reaction
Measured: 24 hours
Feasibility of the patch
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
Measured: 24 hours
Secondary outcomes (3)
Diagnosis performances
Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.
Measured: 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
Measured: 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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Sep 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Mar 2023
Why it stopped: Study site was changed to another countr
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnchocerciasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Research on Filariasis and Other Tropical Diseases, Cameroon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035174
- Sponsor's protocol ID
- C18-56
- Acronym
- EOLoa
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2019
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
- ClinicalTrials.gov ID
- NCT04035174
- Acronym / sponsor ID
- EOLoa / C18-56
- Conditions
- Onchocerciasis, Loiasis, Diagnoses Disease, Neglected Diseases
- Keywords
- Health Public
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study site was changed to another countr
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center for Research on Filariasis and Other Tropical Diseases, CameroonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
| Arm | Type | Receives |
|---|---|---|
| LTS-2 DEC patch | Experimental | Diagnostic Test: LTS-2 DEC patch, Diagnostic Test: Skin snipsThis is a transdermal device with diethylcarbamazine (DEC) applied directly on the skin. The reading will be done 24 hours after. |
| Skin snip | Active comparator | Diagnostic Test: LTS-2 DEC patch, Diagnostic Test: Skin snipsA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All voluntary adults
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTS-2 DEC patchAfter 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 | LTS-2 DEC patch, Skin snip |
| Skin snipsRegarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours. | Diagnostic test | LTS-2 DEC patch, Skin snip |
Primary outcome
Tolerability of the patch
Time frame: 24 hours
Proportion of individuals having developed a generalized Mazzotti's reaction
Feasibility of the patch
Time frame: 24 hours
Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.
3 secondary outcomes
Diagnosis performances
Time frame: 24 hours
Loiasis and cross-reactivity assessment
Time frame: 24 hours
Semi-quantitative scoring of the LTS-2 DEC patch results
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTS-2 DEC patch and Skin snips in people with Onchocerciasis and Loiasis, run by Center for Research on Filariasis and Other Tropical Diseases, Cameroon at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the patch (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.