In Vivo Testing : A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety, Efficacy, and Preventative Effect of a Head Lice Physically Acting Product: 2 in 1 SHAMPOO EU VERSION (X92001483) vs NIX CREME RINSE (1% Permethrin) in Subjects With Head Lice.
Oystershell NV
Summary
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
Description
Compare Safety, Efficacy and preventative effect of a medical device with a physical mode of action against Nix Cream Rinse (1% Permethrin) in Subjects with Head Lice in a two-arm, randomized, controlled, Investigator/Assessor-blinded comparative study.
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Gender: male / female. 2. 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 unders…
Interventions
- DeviceMedical Device (X92001483)
Treatment 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.
Location
- LSRNMaitland, Florida