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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
well established medical device shampoo for the treatment of head lice infestation - Pouxit ®
CIDP
Phoenix, Mauritius
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: 7 days
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: 14 days
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.
Time frame: Day 7
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.
Time frame: Day 0 and Day 7 if applicable
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.
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, Day 1, Day 7, Day 8 and Day 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: * A questionnaire at day 1 consisting of 16 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 2 questions with a binary scale (yes, no). * A questionnaire at end of study (day 7 or day 14) consisting of 9 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 4 questions with a binary scale (yes, no).
Time frame: Day 1 , Day 7 or Day 14 if applicable
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