A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer alone for the treatment of dermatophytic onychomycosis (toenail) without matrix involvement - ONICO

Pierre Fabre Dermatologie0 个研究点目标入组 260 人开始时间: 2009年5月28日最近更新: 2022年4月4日

试验速览

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•Relating to the population:
•-Over 18 year-old male or female patient
•-Patient who has signed the informed consent form
•-Patient willing to attend the planned study visits at the investigational centre and to comply with all study requirements
•-If required by national regulations, patient must be registered with health social security or health insurance
•-Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
•-Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit
•Relating to the disease:
•-Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement
•-Target nail plate showing between 25% and 60% of clinically infected area
•-Patient must have at least 2 mm of unaffected proximal nail area
•-Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
•Are the trial subjects under 18? no
•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

•Relating to the population:
•-Female patient who is pregnant or planning a pregnancy during the course of the study or breast feeding
•-Patient who is unable to understand the information (for linguistic or psychiatric reasons) and to give his/her consent to participate
•-Patient who has forfeited his/her freedom by administrative or legal decision or under guardianship
•-Patient with known hypersensitivity to investigational products’ ingredient(s)
•-Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit
•Relating to the disease:
•-Patient with more than 3 affected toenails
•- Patient with onychomycosis with matrix involvement
•-Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
•-Patient with moccasin-type tinea pedis
•-Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to toenails within 2 months prior to screening visit

发起方