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Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

P

ParaSonic

Status

Completed

Conditions

Pediculus Capitis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

6+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

treatment
Experimental group
Treatment:
Device: The Lucy ultrasonic comb models A and B combined with the LucyGel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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