Pediculus Capitis
Conditions
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
Interventions
DEVICEThe Lucy ultrasonic comb models A and B combined with the LucyGel
Sponsors
ParaSonic Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of the device and treatment | up to three days | measured by AE |
Secondary
| 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 |
Countries
Israel
Outcome results
None listed