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OpenTrials
Completed

NCT Number: NCT02854878

Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.

23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B

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Key information

Conditions

Pediculus Capitis

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzeliya medical center

Herzliya, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females
  • Age 6 years and older at the time of enrollment
  • Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
  • Hair must be at least 3 cm long.
  • Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
  • For females of childbearing potential, a statement declaring that she is not currently pregnant.

Exclusion criteria

  • Used any chemical head lice treatment in the 7 days preceding the trial treatment
  • Used antibiotics in the week preceding treatment
  • Open wounds in the treatment area
  • Skin irritation in the treatment area
  • Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
  • Known allergies to any of the gel's components
  • Participant that is already enrolled in another study
  • Participant who can't be combed with fine Comb dense ASSY2000

Treatment and study plan

The Lucy ultrasonic comb models A and B combined with the LucyGel

Device

Primary outcomes

  1. Adverse events of the device and treatment

    Time frame: up to three days

    measured by AE

Secondary outcomes

  1. Mortality of up to 70% of the mature head lice 3 hours post treatment

    Time frame: 3 hours post treatment

  2. Mortality of up to 50% of the head lice eggs 14 days post treatment.

    Time frame: 14 days post treatment

Sponsors and collaborators

Lead sponsor

ParaSonic Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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