Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device shampoo for lice infestation treatment compared to a comparator device, already in market.
Healthy participant,
Female or male participants,
Aged 2 years and above (for participants in arms 1 and 2),
Aged 3 years and above (for participants in arms 3) ,
Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
Participant in a social or sanitary establishment;
Participant being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.
Parallel
INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes
Other interventionNew medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes
Other interventionNew medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
COMPARATOR DEVICE, Pouxit ®
Other interventionwell established medical device shampoo for the treatment of head lice infestation - Pouxit ®
Cure Rate after complete treatment
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
Cure Rate after complete treatment
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
Cure rate after one dose of Investigational device (ID)
Comparison of the percentage of participants cured after one dose of the investigational device at 2 minutes compared to the percentage of participants cured with the investigational device at 5 minutes ( after one dose) , compared to the percentage of participants cured with one dose and two doses of the comparator device.
Number of dead and live lice/nymphs after treatment
Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb after treatment. Counting will be done visually using dermatoscope.
Number of live lice and nymphs, after application of treatment
Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb one day after treatment. Counting will be done visually using dermatoscope.
Number of participants with treatment-related adverse events as assessed by investigator
Evaluation of the safety and tolerability of the investigational device versus comparator
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