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Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02854878
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
ParaSonic Ltd.

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pediculus Capitis Device: The Lucy ultrasonic comb models A and B combined with the LucyGel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Arm Intervention/treatment
Experimental: treatment Device: The Lucy ultrasonic comb models A and B combined with the LucyGel



Primary Outcome Measures :
  1. Adverse events of the device and treatment [ Time Frame: up to three days ]
    measured by AE


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854878


Locations
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Israel
Herzeliya medical center
Herzliya, Israel
Sponsors and Collaborators
ParaSonic Ltd.

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Responsible Party: ParaSonic Ltd.
ClinicalTrials.gov Identifier: NCT02854878     History of Changes
Other Study ID Numbers: CL-001
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No