EUCTR2013-005595-17-IT进行中（未招募）1 期
Multicentre, open label study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis
Polichem S.A.0 个研究点目标入组 35 人开始时间: 2014年1月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •1. Written Informed Consent given by the patient and
- •parents/Guardians and in any case before starting any study
- •related procedures; 2. Patients of both genders, aged between 2 and 17 years at the time of the written informed consent with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (DSO) without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis (WSO); 3. Patients with positive KOH examination from the target nail chosen at screening; 4. Patients with positive culture for dermatophyte from the target nail chosen at screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with history of allergic reactions to terbinafine and/or to
- •any of the other ingredients of P-3058; 2. Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant; 3. Patients with onychomycosis caused by yeasts or nondermatophytes mould; 4. Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate). Patients with mildto-moderate tinea pedis using a topical antifungal treatment will be included; 5. Congenital or acquired nail dystrophy (i.e. Darier’s disease); 6. Patients with nail psoriasis; 7. Patients with nail changes due to eczema, lichen planus or alopecia areata; 8. Patients with one-hand two-foot syndrome; 9. Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it; 10. Use of systemic antifungal drugs in the 6 months prior to screening visit; 11. Use of topical nail antifungal drugs in the four weeks prior to screening visit; 12. Habitual finger sucking during the night in children that have fingernail onychomycosis if it cannot be prevented by parents; 13. Female subjects physiologically capable of becoming pregnant are asked to refrain from any sexual intercourse during the whole study duration or to use acceptable methods of contraception
- •agreed with the investigator; 14. Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study or who
- •become pregnant.
研究者
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