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

Study Overview

• Status: Completed
• Conditions: Pediculus Capitis
• Intervention / Treatment: Device: The Lucy ultrasonic comb models A and B combined with the LucyGel

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Herzliya, Israel
    • Herzeliya medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of the device and treatment	measured by AE	up to three days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality of up to 70% of the mature head lice 3 hours post treatment	3 hours post treatment
Mortality of up to 50% of the head lice eggs 14 days post treatment.	14 days post treatment

Collaborators and Investigators

• Sponsor: ParaSonic Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 31, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No