E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
the patient who will be included in this clinical trial present a confirmed active head lice infestation. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to assess the non inferiority of malathion 0.5% lotion (V3777 A) versus Prioderm® lotion (0.5% Malathion), in the cure of the head lice 12 days after one single application. The cure is defined by the absence of live lice. |
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E.2.2 | Secondary objectives of the trial |
the secondary objectives are: - To assess the head lice infestation, 2 days after one single application of the lotion, - To assess the local and general tolerability of the lotions, - To assess the cosmetic acceptability of the two lotions. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Will be eligible patients who meet the following criteria: - Patients aged 2 years or more, - confirmed active head lice infestation, with at least 5 live lice of the half-head (adult lice and nymphs), - patients accepting not to use any product in the same indication during the study period, - parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study, - negative urine pregnancy test at inclusion for woman of child bearing potential, - use an efficient method of contraception (oral contraceptive, intra-uterine device, tubal ligature), for women of child bearing potential, for at least 2 months, during all the study and until 1 month after the end of the study, - patient accepting to participate to the study and to give a written informed consent, - able to understand the protocol and to come to the control visits, and comply with all trial requirements, - registered with the a social security or health insurance system if required by law |
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E.4 | Principal exclusion criteria |
Will not be included patients who have one of the following criteria:
* Criteria related to the pathology: - patients having only nits without live lice on the scalp, - patient who has a history of a major medical/psychiatric illness or surgery which, in the judgement of the investigator, may interfere with study medication, metabolism and/or study implementation and/or study parameter assessment(s).
* Criteria related to treatments: - patient with a history of hypersensitivity to head lice product or at least to one ingredient in the inclusion visit, - patient using a pediculicidal and/or an ovicidal product within the month prior to entering the study, - patient who has received an Ivermectine treatment within the month prior the inclusion visit, - patient who has received oral or parenteral trimethoprim/sulfamethoxazol within the month prior the inclusion visit, - patient using regularly a medical and/or cosmetic topical product on the scalp.
* Criteria related to the population: - female who is pregnant or breast feeding or not using contraception, or planning to become pregnant, - participation to an other clinical trial in the previous month before the inclusion visit or during the study, - patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary criterion for the Efficacy: - cure rate of head lice 12 days after one single application of the lotion, this criterion will be assessed by the rate of patients without live lice on day 12 (D12).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |