Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

Pediculus Capitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854878
• Other study ID #: CL-001
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: July 26, 2018

Study information

• Verified date: March 2019
• Source: ParaSonic Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediculus Capitis

Intervention

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

Locations

Country	Name	City	State
Israel	Herzeliya medical center	Herzliya

Sponsors (1)

Lead Sponsor	Collaborator
ParaSonic Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of the device and treatment	measured by AE	up to three days
Secondary	Mortality of up to 70% of the mature head lice 3 hours post treatment		3 hours post treatment
Secondary	Mortality of up to 50% of the head lice eggs 14 days post treatment.		14 days post treatment