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 for lice infestation treatment compared to a comparator device, already in market.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
new medical device for the treatment of head lice infestation: Paranix ®
well established medical device for the treatment of head lice infestation (dimethicone based) - Pouxit ®
Céline Lhéritier
Quatre Bornes, Mauritius
RECRUITINGCure 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.
Time frame: day 7
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.
Time frame: day 14
Cure rate after one dose of Investigational device (ID)
Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with two doses of the comparator device.
Time frame: Day 7
Dead and live lice/nymphs and number of eggs after combing
Number of dead and live lice/nymphs and number of eggs collected on the anti-lice comb after treatment
Time frame: Day 0 and Day 7 if applicable
Live lice and nymphs, after application
Evaluation of the presence of live lice and nymphs, for both groups, without combing on scalp
Time frame: Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator
Evaluation of the safety and tolerability of the investigational device versus comparator
Time frame: Day 0, 7, 8 and 14 if applicable
Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data
Evaluation of the perceived acceptability, effectiveness and subjective evaluation. Subject perception questionnaire with the following scale items: totally agree agree rather agree rather disagree disagree
Time frame: Day 7 or Day14
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