Evidence map›Paper›PMID 28488042›Full record

Trial reportParasitology research2017

Randomized, investigator-blinded, controlled clinical study with lice shampoo (Licener®) versus dimethicone (Jacutin® Pedicul Fluid) for the treatment of infestations with head lice.

Margit Semmler, Fathy Abdel-Ghaffar, Falk Gestmann, Mohammed Abdel-Aty, Ibrahim Rizk, Saleh Al-Quraishy, Walter Lehmacher, Norman-Philipp Hoff

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Parasitology research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
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

8 authors at 5 institutions in 3 countries.

Margit SemmlerDepartment of Zoology, Faculty of Science, Cairo University, Giza, Egypt.
Fathy Abdel-GhaffarDepartment of Zoology, Faculty of Science, Cairo University, Giza, Egypt.
Falk GestmannAlpha-Biocare GmbH, Neuss, Germany. Gestmann@alphabiocare.de.
Mohammed Abdel-AtyEl-Santa Medical Province, Ministry of Public Health, Cairo, Egypt.
Ibrahim RizkEl-Fath Clinical Hospital, Kafr El-Sheikh, Egypt.
Saleh Al-QuraishyDepartment of Zoology, College of Science, King Saud University, Riyadh, Saudi Arabia.
Walter LehmacherInstitute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.
Norman-Philipp HoffClinic for Dermatology, Heinrich-Heine-University, Düsseldorf, Germany.
Cairo University · EGHeinrich Heine University Düsseldorf · DEKafrelsheikh University · EGKing Saud University · SAUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The present clinical trial was conducted to obtain additional data for the safety and efficacy of a head lice shampoo that is free of silicone compared with an anti-head lice product containing dimethicone. Both products act by a physical mode of action. This randomized, investigator-blinded, controlled clinical study was conducted between July and November 2016 in households of two villages (Abou Rawash and Shandalat) in Egypt. Children older than 2 years with an active head lice infestation were treated with either a shampoo-based head lice treatment containing neem extract (Licener®) or dimethicone (Jacutin® Pedicul Fluid) on day 1 and additionally on day 9. Assessment for living lice by combing was conducted before and 1-2 h after treatment and on days 5 and 13. The main objective was to demonstrate a cure rate of the test product of at least 85% after a single application (day 5 and 9). Secondary objectives were to scrutinize patient safety and satisfaction as well as cure rates on day 13 after two treatments and the evaluation of ovicidal and licicidal efficacies of the products. Sixty-one children in the test-group (Licener®) and 58 children in the reference group (Jacutin® Pedicul Fluid) were included in this study. The test product and the reference product were very well tolerated. Both products exceeded the objective of cure rates of over 85% after single treatment (test group 60/60 = 100%; 95% CI = 94.04-100.00%; reference group 54/57 = 94.74%; 95% CI = 85.38-98.90%; p = 0.112; CI by Clopper-Pearson) and after two treatments (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 52/54 = 96.30%; 95% CI = 87.25-99.55%; p = 0.230) with higher cure rates and non-inferiority for the test product. The combined success rate shows significant superiority of the test product against the reference product (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 49/54 = 90.7%; 95% CI = 79.70-96.92%; p = 0.024). The test product showed higher ovicidal efficacy than the reference product. Thus, the present study demonstrates that a single treatment with a head lice product like Licener® can be sufficient to eliminate a head lice infestation.

Indexed as

AnimalsChildChild, PreschoolDimethylpolysiloxanesEgyptFemaleHexachlorocyclohexaneHumansInsecticidesLice InfestationsMalePediculusdimethiconeDimethylpolysiloxanesHexachlorocyclohexaneInsecticidesBlindedClinical studyClinical trialControlledHead licePediculus humanus capitisRandomizedShampooTreatment

Identifiers

PMID28488042
OpenAlexW2612622180

What OpenQuestion holds

Textmetadata
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.