To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
Gender: male / female.
The subject or his/her parent/legal guardian (from age 12-17) must give written informed consent (after having been informed orally and by written text about the benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study). A caregiver must sign an informed consent agreement for children not old enough to do so. Children aged 6-11 years of age will be administered a child's assent form. The subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
Age ≥ 1 year of age at the time of enrollment.
Subject agree to not use any other anti-lice or preventative treatment or medicated hair grooming products for the duration of the study (through last visit day- Day 14).
Application of any form of head lice treatment, whether prescription or over-the counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1).
Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit.
Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
Parallel
Medical Device (X92001483)
DeviceTreatment of subjects with Head Lice with a medical device (X92001483) with a physical mode of action on day 0, day 7, day 10, day 13 and day 14.
Preventative Effect
Determin whether subjects treated with the medical device X92001943 after treatment with Nix Creme Rinse maintain a higher cure rate at the end of the study compared with subjects treated only with Nix Creme Rinse.
Maintenance of cure rate over time
To assess the maintenance of cure over time: To compare cure rates between subjects treated with Nix Creme Rinse and the medical device X92001483 at interim visits in order to evaluate the presence and persistence of the preventive effect of the investigational product relative to standard of care product (Nix creme rinse) alone.
Time to re-infestation
Characterize the time to re-infestation in each treatment group
Number of live lice
To compare the number of live lice detected at each assessment across treatment groups.
Local tolerability
To evaluate the local tolerability of the standard of care product and investigational product, as measured by subject reported symptoms (eg: burning, paraesthesia, pruritus) following application.
Scalp and skin irritation
To evaluate scalp and skin irritation by study staff (secondary infection, erythema, excoriation) following product application.
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Oystershell NV
Lead sponsor
LSRN Research
Collaborator
