Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of Antifungal Activity of Loceryl Nail Lacquer
研究概览
简要总结
The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.
The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
详细描述
Study center:
A total of 50 subjects were to be included in 1 site in Iceland.
Methodology:
-
Group Loceryl Nail Lacquer+ Cosmetic Varnish:
-
Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
-
Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
-
Group Loceryl Nail Lacquer alone:
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)
盲法说明
Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized.
15 months of treatment with Loceryl NL alone had an open study design
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 a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
- •Subjects must have maximum of 50% of nail distal edge involved
- •Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening
排除标准
- •Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
- •Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
- •Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
研究组 & 干预措施
Investigator blinded Loceryl NL+ Cosmetic varnish
Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails
干预措施: Loceryl NL + Cosmetic varnish (Drug)
Investigator blinded Loceryl NL+ Cosmetic varnish
Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails
干预措施: Loceryl NL 15 months (Drug)
Investigator blinded Loceryl NL alone
Loceryl NL once/week for 12 weeks on right or left foot toenails
干预措施: Loceryl NL 12 weeks (Drug)
Investigator blinded Loceryl NL alone
Loceryl NL once/week for 12 weeks on right or left foot toenails
干预措施: Loceryl NL 15 months (Drug)
结局指标
主要结局
Measurement of Antifungal Activity of Loceryl Nail Lacquer
时间窗: Week 12
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
次要结局
- Absence of Dermatophytes in Nail Samples Culture(Week 12)