Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation.
Healthy subject (except head lice infestation) based on medical history;
Gender: male or female;
Age: 2 years and above at the time of enrolment ;
Subject with a slight to moderate lice infestation (according to EU norms)
In terms of population
Pregnant (confirmed by pregnancy test at D0 for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
Subject in a social or sanitary establishment;
Parallel
Pulverize (X92001919)
DeviceTreatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)
Paranix Anti-Lice Shampoo
DeviceTreatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo
Efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampo.
Evaluate the efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampoo on the treatment of head lice infestation, after one treatment consisting of 3 applications. Efficacy of the treatment will be defined as the cure rate at the end of day 10, corrected for re-infestation.
Efficacy comparison (uncorrected for re-infestation)
Evaluate and compare the efficacy for both products. (cure rate at the end of day 10, uncorrected for re-infestation).
Cure rate on day 3 and day 7
Evaluation of the cure rate on day 3 and day 7 in both separate groups, and comparison of both product effect after only one (on day 3) or two applications (day 7 for Pulverize versus day 10 for Paranix).
Indirect efficacy on eggs and evaluate potential re-infestation
Presence of live lice and nymphs, for both groups and between groups, without combing on hair and close to scalp on day 0 (prior to treatment to assess severity of the infestation), day 3, day 7, and day 10. These evaluations will assess indirect efficacy on eggs and evaluate potential re-infestation.
General well-being of subject (Esthetical effect)
Analysis of subject's (or subject's parents/guardians) questionnaire at day 0 and day 7 to evaluate esthetical effect of the product. A comparison of the answers will be performed between the two products.
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Oystershell NV
Lead sponsor
Eurofins Dermscan Pharmascan
Collaborator
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