PMID- 31647007
OWN - NLM
STAT- MEDLINE
DCOM- 20200413
LR  - 20200413
IS  - 1471-5945 (Electronic)
IS  - 1471-5945 (Linking)
VI  - 19
IP  - 1
DP  - 2019 Oct 18
TI  - High efficacy of a dimeticone-based pediculicide following a brief application: 
      in vitro assays and randomized controlled investigator-blinded clinical trial.
PG  - 14
LID - 10.1186/s12895-019-0094-4 [doi]
LID - 14
AB  - BACKGROUND: Increasing 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. METHODS: We 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. RESULTS: After 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. CONCLUSIONS: We 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 REGISTRATION: EU Clinical Trials Register EudraCT  
      2016-004635-20 . Registered 14 November 2016.
FAU - Heukelbach, Jorg
AU  - Heukelbach J
AUID- ORCID: 0000-0002-7845-5510
AD  - Department of Community Health, School of Medicine, Federal University of Ceara, 
      Rua Professor Costa Mendes 1608, 5. andar, Fortaleza, CE, 60430-140, Brazil. 
      heukelbach@web.de.
FAU - Wolf, Doerte
AU  - Wolf D
AD  - CardioSec Clinical Research GmbH, Dalbergsweg 21, 99084, Erfurt, Germany.
FAU - Clark, John Marshall
AU  - Clark JM
AD  - Department of Veterinary & Animal Sciences, Massachusetts Pesticide Analysis Lab, 
      University of Massachusetts Amherst, Amherst, MA, 01003, USA.
FAU - Dautel, Hans
AU  - Dautel H
AD  - IS Insect Services GmbH, Motzener Strasse 6, 12277, Berlin, Germany.
FAU - Roeschmann, Kristina
AU  - Roeschmann K
AD  - G. Pohl-Boskamp GmbH & Co. KG, Kieler Strasse 11, 25551, Hohenlockstedt, Germany.
LA  - eng
SI  - EudraCT/EudraCT 2016-004635-20
PT  - Equivalence Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191018
PL  - England
TA  - BMC Dermatol
JT  - BMC dermatology
JID - 100968541
RN  - 0 (Dimethylpolysiloxanes)
RN  - 0 (Insecticides)
RN  - 509F88P9SZ (Permethrin)
RN  - 92RU3N3Y1O (dimethicone)
SB  - IM
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Animals
MH  - Child
MH  - Child, Preschool
MH  - Dimethylpolysiloxanes/adverse effects/pharmacology/*therapeutic use
MH  - Female
MH  - Humans
MH  - In Vitro Techniques
MH  - Insecticides/adverse effects/pharmacology/*therapeutic use
MH  - Lice Infestations/*drug therapy
MH  - Male
MH  - Pediculus/*drug effects
MH  - Permethrin/pharmacology/*therapeutic use
MH  - Scalp Dermatoses/*drug therapy
MH  - Single-Blind Method
PMC - PMC6806501
OTO - NOTNLM
OT  - Body lice
OT  - Clinical trial
OT  - Dimeticone
OT  - Head lice
OT  - Ovicidal activity
OT  - Pediculicidal activity
COIS- KR is an employee of Pohl-Boskamp and was involved in drafting the manuscript, 
      revising it critically for important intellectual content, ensuring that 
      questions related to accuracy and integrity of the work are resolved. 
      Pohl-Boskamp engaged the CRO CardioSec Clinical Research GmbH to design and 
      perform the clinical trial. Principle investigator was DW, who is managing 
      director of CardioSec Clinical Research. Pohl-Boskamp provided salaries to JC and 
      HD on a work-for-hire basis and remunerated the CRO CardioSec Clinical Research 
      GmbH for their services in performing the study. DW is a company member of 
      CardioSec Clinical Research GmbH without any financial or personal interest in 
      the test product. JH has been an independent scientific consultant to 
      Pohl-Boskamp GmbH & Co. KG.
EDAT- 2019/10/28 06:00
MHDA- 2020/04/14 06:00
PMCR- 2019/10/18
CRDT- 2019/10/25 06:00
PHST- 2019/04/25 00:00 [received]
PHST- 2019/09/20 00:00 [accepted]
PHST- 2019/10/25 06:00 [entrez]
PHST- 2019/10/28 06:00 [pubmed]
PHST- 2020/04/14 06:00 [medline]
PHST- 2019/10/18 00:00 [pmc-release]
AID - 10.1186/s12895-019-0094-4 [pii]
AID - 94 [pii]
AID - 10.1186/s12895-019-0094-4 [doi]
PST - epublish
SO  - BMC Dermatol. 2019 Oct 18;19(1):14. doi: 10.1186/s12895-019-0094-4.