ON INFERIORITY STUDY OF A MALATHION 0.5% LOTION VERSUS REFERENCE THERAPY IN THE TREATMENT OF HEAD LICE: MULTICENTRE, RANDOMISED, INVESTIGATOR MASKED, PARALLEL GROUP. - ND
- Conditions
- the patient who will be included present a confirmed active head lice infestation
- Registration Number
- EUCTR2007-001844-34-IT
- Lead Sponsor
- Pierre Fabre Dermocosmetique
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method