Evidence map›Paper›PMID 26452723›Full record

Trial reportParasites & vectors2015

Diagnosis of O. volvulus infection via skin exposure to diethylcarbamazine: clinical evaluation of a transdermal delivery technology-based patch.

K Awadzi, Nicholas O Opoku, Simon K Attah, Janis K Lazdins-Helds, Annette C Kuesel

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Parasites & vectors, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 4 countries.

K AwadziOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana.
Nicholas O OpokuOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana. opokuopn@hotmail.com.
Simon K AttahOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana. skwakuattah@yahoo.com.
Janis K Lazdins-HeldsUNICEF/UNDP/World Bank/ WHO Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland. lazdinsj@gmail.com.
Annette C KueselUNICEF/UNDP/World Bank/ WHO Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland. kuesela@who.int.
World Health Organization · CHOncotherapeutics (United States) · USUniversity of Ghana · GH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundElimination of onchocerciasis in Africa is now regarded as an achievable goal in many areas. This makes monitoring changes in infection prevalence a key component of control programmes. Monitoring is currently based on determining the presence of O. volvulus microfilariae in skin snips, an invasive, labour-intensive method. The Onchocerciasis Control Programme (OCP) had established procedures to detect O. volvulus infections via the localized skin reaction induced by killing of microfilariae upon skin exposure to diethylcarbamazine via a patch (OCP-patch). Large scale OCP - patch use is difficult due to labour-intensive patch preparation. At the request of TDR, a manufacturer specialized in transdermal-delivery systems developed a ready-to-use diethylcarbamazine (DEC) containing patch (LTS-2 patch). To qualify this patch for large scale studies of its sensitivity and specificity, this study evaluated its ease of application, ability to detect infection and DEC exposure related adverse reactions compared to the OCP-patch in 30 infected individuals.

methodsEach participant with 0.2-36.8 O. volvulus microfilariae/mg skin received the OCP-patch and 4 days later the LTS-2 patch at the left and right iliac crest, respectively, for 24 h. Presence and characteristics of local skin reactions were assessed at patch removal and 6 h later. Skin reaction and Mazzotti reaction rates were compared with Fisher's exact and a paired t-test, respectively.

resultsThe LTS-2 patch could be applied within 10 s. Mild itching occurred at 63.3 % of OCP-patch (duration 8.9 ± 11.8 h) and 26.7 % of LTS-2 patch sites (duration 1.0 ± 2.5 h) and was the most frequent Mazzotti reaction. At patch removal after 24 h, a diagnostic local skin reaction was present under 90 % of OCP-patches and 83 % of LTS-2 patches; 6 h later, it was present at 93 % of OCP-patch and 100 % of LTS-2 patch sites.

conclusionsThe data suggest that safety, tolerability and ability to detect infections of the LTS-2 patch are comparable to those of the OCP-patch. They qualify the LTS-2 patch for field studies to determine LTS-2 patch sensitivity, specificity and utility during large scale use and thus to inform use of the LTS-2 patch by onchocerciasis control programmes to determine prevalence of infection.

trial registrationCurrent controlled Trials ISRCTN76875372 .

Indexed as

Administration, CutaneousAdolescentAdultAnimalsDiethylcarbamazineFemaleFilaricidesHumansMaleMiddle AgedOnchocerca volvulusOnchocerciasisSkinYoung AdultDiethylcarbamazineFilaricides

Identifiers

PMID26452723
PMCPMC4598973
OpenAlexW2114021676

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.