Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

Not Applicable

Completed

• Conditions: Pediculus Capitis
• Interventions: Device: The Lucy ultrasonic comb models A and B combined with the LucyGel

• Registration Number: NCT02854878
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-31
• Study First Posted: 2016-08-04
• Study Start: 2016-11-28
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	The Lucy ultrasonic comb models A and B combined with the LucyGel	-

Primary Outcome Measures

Name	Time	Method
Adverse events of the device and treatment	up to three days	measured by AE

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Herzeliya medical center; 🇮🇱 Herzliya, Israel