Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

Study Overview
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Brief Summary
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THe main goal of our randomized controlled trial with blinded observer will be to compare four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority (20% equivalence). THe randomization will be balanced every 10 families. The secondary objective will be to compare the lenticide efficacy of the products and their local tolerance and cosmetic acceptibility.

Official Title
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Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)

Conditions
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Headlice Infections

Intervention / Treatment
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* Device: Paranix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject-male or female, child > 3 years and adult Pediculosis of scalp, confirmed by the identification of minimum 5 live lice with a fine-tooth comb Negative urine pregnancy test before inclusion for women of childbearing potential Use of a contraceptive method by hormonal contraceptives or IUDs or tubal ligation or condoms for women of childbearing potential Subject agreeing to participate in the study with written informed consent for participation Written consent of both parents for the minor patients. Exclusion Criteria: Children under 3 years. Woman pregnant or lactating or without contraception Use of a pediculicide or lenticide treatment within 2 weeks before entry into the study Subject with known hypersensitivity to any component of the tested products Subject who participated in a clinical study in the 3 months prior to inclusion Ongoing treatment potentially interacting with the treatment under study (other pediculicide products) Subject undertreatment susceptible to influence the evaluation of the trial (including trimethoprim-sulfamethoxazole). Severe medical or psychiatric illness considered by the investigator as potentially dangerous to the subject or incompatible with the conduct of the study Asthma Subject unable for linguistic or psychiatric reasons to understand the information and give informed consent Subject refusing to give written consent Subject deprived of his liberty by administrative or judicial decision, or guardianship Patient hospitalized in a medical or social facility for another reason that biomedical research

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Paranix|pediculicide product|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistical analysis will compare the number of successes and failures for each products |  | Day 1, Day 7 and day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head lice