EUCTR2015-001237-24-DE进行中（未招募）1 期
Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Ciclopoli® Nail Lacquer.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •INCLUSION CRITERIA
- •In general, the investigator will enrol subjects with heterogeneous disease characteristics regarding affected toenails within the limits defined below.
- •1.Male or female subjects aged 18 years or older,
- •2.Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit,
- •3.Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
- •4.Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
- •5.Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline. The exams will be performed by the Mycological Laboratory as usual in routine practice,
- •6.Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline must use an effective method of contraception during the study: oral/systemic (injectable, patch, etc. contraception must have been on a stable dose for 3 months prior to study entry), bilateral Tubal Ligation, hormonal Intra-Uterine Device IUD (inserted at least 1 month prior to screening), strict abstinence,or partner had a vasectomy,
- •7.Females of non-childbearing potential, defined as post-menopausal (absence of menstrual bleeding for 1 year), hysterectomy, or bilateral oophorectomy,
- •8.Subjects must understand, sign and receive a copy of an informed consent at Screening prior to any investigational procedure being performed,
- •9.Subjects must be able and willing to cooperate to the extent and degree required by the protocol (including refraining from using cosmetic nail products on the affected toenails during the study).
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •EXCLUSION CRITERIA
- •Any subject who meets one or more of the following criteria will not be included in the study.
- •1.The subject with a surgical, medical condition or clinically important abnormal physical findings which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy),
- •2.Post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject’s compliance of the investigational products, or mask the effects of treatment (cure),
- •3.Known immunodeficiency, radiation therapy, immune suppressive drugs,
- •4.Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
- •5.Subjects needing to use any procedure or product (i.e. topical nail treatment, care or cosmetic lacquer) other than the investigational products on the toenails or surrounding skin during the study,
- •6.Any other treatments which at the investigator’s judgment are liable to interfere or interact with the safety of study evaluation,
- •7.Subjects with known sensitivity to any of the study preparations (see Summary of Products Characteristics - SmPC),
- •8.Subjects participating in a clinical research study within the last 30 days prior to enrollment,
- •9.Subjects under guardianship, hospitalized subjects in a public or private institution for a reason other than the research, and subjects deprived of his/her freedom.
研究者
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