Efficacy of Topical Resin Lacquer, Amorolfine, and Oral Terbinafine for Treating Toenail Onychomycosis: a Prospective, Randomized, Controlled, Investigator-blinded, Parallel-group Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Mycological Cure
研究概览
简要总结
The current study is conducted to corroborate the previous observational clinical trial with more valid methods and a more clinically relevant experimental design. This study aims to compare efficacy, safety, and cost between topically administered 30% resin lacquer for the treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5% amorolfine and systemic terbinafine.
详细描述
The aim of this prospective, investigator-blinded, randomized and controlled clinical trial is to explore potential differences between 5 % amorolfine and 30 % resin lacquer in topical treatment of onychomycosis. In addition, topical treatment methods are compared with the most effective 'drug of choice' for onychomycosis according the current guidelines i.e. oral medication with terbinafine.
Altogether 90 patients (the aim is to collect the 30 patients per group) who have culture or potassium hydroxide (KOH) stain verified dermatophyte onychomycosis are randomly allocated into 3 treatment groups to receive either topical treatment or oral medication for toenail onychomycosis classified as follows:
- White superficial onychomycosis (WSO)
- Distal and lateral subungual onychomycosis (DLSO)
- Proximal subungual onychomycosis (PSO)
- [Total dystrophic onychomycosis) (TDO)] [Excluded]
- [Candidal onychomycosis] [Excluded]
Participants are randomized into 3 groups to receive:
- Topical treatment: 30 % resin lacquer (Abicin®) applied once daily for 9 months.
- Topical treatment: 5 % amorolfine lacquer (Loceryl®) applied once weekly for 9 months.
- Oral medication: 250 mg terbinafine taken orally once daily for 3 months.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Positive dermatophyte culture in the beginning of the study obtained from the toenail sample.
- •Positive KOH stain in the beginning of the study obtained from the toenail sample.
排除标准
- •Any other nail disease than dermatophyte culture or KOH stain verified onychomycosis
- •Onychomycosis caused by yeasts or nondermatophyte molds
- •Kidney failure determined by plasma creatinine level (P-Krea > 100 μmol/l)
- •Liver failure determined by plasma γ-glutamyltransferase level (P-GT > 120 U/I)
- •Sensitivity or allergy to Resin, Amorolfine or Terbinafine
- •Potential adverse cross-reaction of Terbinafine, Amorolfine or Resin with the patient's permanent medication
- •Presence of total dystrophic onychomycosis (TDO)
- •Any topical or oral antifungal treatment within the 6 months before the beginning of the study (washout period > 6 months).
研究组 & 干预措施
Resin Lacquer
Topical 30% Resin Lacquer applied once daily for 9 months (Abicin® 30% Nail Lacquer).
干预措施: Resin Lacquer (Device)
Amorolfine
Topical 5% Amorolfine Lacquer applied once weekly for 9 months (Loceryl® 5% Nail Lacquer).
干预措施: Amorolfine (Drug)
Terbinafine
250 mg of Terbinafine taken orally once daily for 3 months (Generics).
干预措施: Terbinafine (Drug)
结局指标
主要结局
Mycological Cure
时间窗: At 4- and 10 months time-points from the beginning of the study.
To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.
次要结局
- Clinical Responses to the Treatments(At 4- and 10 months time-points from the beginning of the study.)
- Cost-effectiveness 2(At 10-month time-point)
- Cost-effectiveness 1(At 10-month time-point)
- Compliance to the Treatment(At 4-month time-point)
研究者
Janne J. Jokinen
Consultant Cardiothoracic Surgeon
Helsinki University Central Hospital