Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- % adherent subjects with applications
研究概览
简要总结
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).
详细描述
A total of 20 subjects are to be included in 1 site in Iceland
Methodology:
Subjects will receive following treatments on the right or left toenails:
-
Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected toenails of one foot (including great toenail)
-
Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases:
-
Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal
-
Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
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
- None
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
- •Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
- •Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
- •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,
- •Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline
排除标准
- •Subjects with matrix involvement on the great toenails,
- •Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
- •Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
- •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 7 weeks on all affected toenails of one foot
干预措施: Loceryl Nail Lacquer (Drug)
Urea Ointment + Bifonazole Cream
On the opposite foot:
- Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal)
- Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
干预措施: Urea Ointment (Drug)
Urea Ointment + Bifonazole Cream
On the opposite foot:
- Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal)
- Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
干预措施: Bifonazole Cream (Drug)
结局指标
主要结局
% adherent subjects with applications
时间窗: Week 7
Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)
% Subjects satisfied to very satisfied with each study treatment at week 7
时间窗: Week 7
Percent of subjects satisfied to very satisfied with each study treatment at week 7
% adherent subjects with nail preparation
时间窗: Week 7
Percent of subjects having prepared affected toenails as instructed for each product before applications: * For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab * For Urea: Soak toenails in warm water and remove soften infected toenails plates * For Bifonazole: Clean and dry thoroughly affected toenails
次要结局
未报告次要终点