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 items have been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimative convenience in use - making treatment of head lice infestation easy, and effective in few minutes. The main objective of this clinical study is to confirm the efficacy on head lice treatment of two Medical Devices, already in market.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
well established medical device for the treatment of head lice infestation (osmolone based)
well established medical device for the treatment of head lice infestation (dimethicone based)
Insight Research
Quatre Bornes, Mauritius
RECRUITINGEfficacy based on the cure rate after complete treatment
The cure rate is defined as the rate of subjects having no live lice on hair 7 days after the last application of the product (Day 7 or Day 14 if second application is needed).
Time frame: Day 7, Day 14 if applicable
Cure rate of each individual investigational device
Evaluate the cure rate of each individual investigational device
Time frame: Day 7, Day 14
Cure rate after one dose of investigational device application
Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with one dose of the comparator device.
Time frame: Day 7
Dead and live lice/nymphs after combing
Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.
Time frame: Day 0, 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 hair and close to scalp
Time frame: Day 1, Day 7, Day 8 if applicable, Day 14 if applicable
Number of participants with treatment-related adverse events, serious 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 if applicable, and Day 14 if applicable
Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire
Evaluation of the perceived acceptability, subjective efficacy and risk of re-infestation; Subject perception questionnaire with the following scale items: totally agree, agree, rather disagree, disagree
Time frame: Day 1, Day 7 or Day 14 if applicable
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