Evidence map›Paper›PMID 31647007›Full record

Trial reportBMC dermatology2019

High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial.

Jorg Heukelbach, Doerte Wolf, John Marshall Clark, Hans Dautel, Kristina Roeschmann

Open access · diamondAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in BMC dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Veterinary world · 2021
    Article
  4. Article
  5. [Parasitoses in childhood].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021
    Review
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 4 institutions in 3 countries.

Jorg HeukelbachDepartment of Community Health, School of Medicine, Federal University of Ceará, Rua Professor Costa Mendes 1608, 5. andar, Fortaleza, CE, 60430-140, Brazil. heukelbach@web.de.ORCID http://orcid.org/0000-0002-7845-5510
Doerte WolfCardioSec Clinical Research GmbH, Dalbergsweg 21, 99084, Erfurt, Germany.
John Marshall ClarkDepartment of Veterinary & Animal Sciences, Massachusetts Pesticide Analysis Lab, University of Massachusetts Amherst, Amherst, MA, 01003, USA.
Hans DautelIS Insect Services GmbH, Motzener Straße 6, 12277, Berlin, Germany.
Kristina RoeschmannG. Pohl-Boskamp GmbH & Co. KG, Kieler Straße 11, 25551, Hohenlockstedt, Germany.
CardioSec (Germany) · DEPohl Boskamp (Germany) · DEUniversidade Federal do Ceará · BRUniversity of Massachusetts Amherst · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncreasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance.

methodsWe performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10.

resultsAfter 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild.

conclusionsWe have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients' compliance.

trial registrationEU Clinical Trials Register EudraCT  2016-004635-20 . Registered 14 November 2016.

Indexed as

Administration, TopicalAdolescentAdultAnimalsChildChild, PreschoolDimethylpolysiloxanesFemaleHumansInsecticidesIn Vitro TechniquesLice InfestationsMalePediculusPermethrinScalp DermatosesdimethiconeDimethylpolysiloxanesInsecticidesPermethrinBody liceClinical trialDimeticoneHead liceOvicidal activityPediculicidal activity

Identifiers

PMID31647007
PMCPMC6806501
OpenAlexW2982050516

What OpenQuestion holds

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LicenceCC BY
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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.