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. Identifier: NCT02854878
Recruitment Status : Unknown
Verified July 2016 by ParaSonic Ltd..
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2016
Last Update Posted : August 4, 2016
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, Device: The Lucy ultrasonic comb models A and B combined with the LucyGel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017

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 ]

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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

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

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