E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
the patient who will be included 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 |
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 14 days after the first application. The cure is defined by the absence of live lice |
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E.2.2 | Secondary objectives of the trial |
- 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 |
- 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 women of childbearing 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, - a written informed consent for the children able to understand and to give the consent, - registered with a social security or health insurance system if required by law. |
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E.4 | Principal exclusion criteria |
* Criteria related to the pathology - patients having only nits without live lice on the scalp, - history of epilepsy or convulsion, - 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 who has received metronidazole within the month prior the inclusion visit, - patient using regularly a medical and/or cosmetic topical product on the scalp, Non inclusion criteria (following): * Criteria related to the population - young girl of childbearing potential without an efficient method of contraception at least 2 months will not be included, - 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 / parent(s) or guardian(s) who is (are) not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - patient / parent(s) or guardian(s) who has (have) forfeited his/her/their 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) |
cure rate of head lice 14 days after the first application of the lotion, this criterion will be assessed by the rate of patients without live lice on day 14 (D14) |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
STESSO FARMACO ALTRA FORMULAZIONE DEGLI ECCIPIENTI |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |