Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

NCT02854878 | Completed

• 1 other identifier: CL-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Pediculus Capitis

Outcome Measures

Primary Outcomes (1)

• Adverse events of the device and treatment

  measured by AE

  up to three days

Secondary Outcomes (2)

• 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

Study Arms (1)

treatment

EXPERIMENTAL

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

Interventions

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

treatment

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ParaSonic Ltd.: lead

Study Sites (1)

Herzeliya medical center

Herzliya, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 4, 2016
• Study Start: November 28, 2016
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

IL (1)