Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 20
- 主要终点
- Percent of "in Label" Adherent Subjects
研究概览
简要总结
The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
详细描述
A total of 20 subjects are to be included in 1 site in Germany.
Methodology:
Subjects will receive the following treatments on the right or left toenails:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
- Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •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,
- •Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline,
- •Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
排除标准
- •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),
- •Subjects with 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),
- •Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.
研究组 & 干预措施
Loceryl NL
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
干预措施: Loceryl NL (Drug)
Ciclopirox NL
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
干预措施: Ciclopirox NL (Drug)
结局指标
主要结局
Percent of "in Label" Adherent Subjects
时间窗: Week 12
Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks)
次要结局
- Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12(Week 12)