Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number of study subjects with a reduction in infected nail area at 6 months.
研究概览
简要总结
This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.
详细描述
The purpose of this clinical trial is to determine the safety and effectiveness of the medical device ABL01. The intended use of ABL01 is to reduce and treat onychomycosis, fungal nail infection. ABL01 is a solution intended to be topically administered weekly to infected nails. The trial is designed as a double blinded randomized placebo controlled clinical trial. The trial involves 70 study subjects, half of which will receive ABL01 and the other half placebo. The inclusion criteria for study subjects are adult men and women that present with distal lateral subungual onychomycosis (DSU) on the big toe nails. Furthermore, the extent of DSU should not involve more than half of the area of the nail.
The study subjects will themselves apply the study solution weekly to the treated nail. The trial will run for 6 months with a possible extension to maximum 12 months. There will be a total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the trial. The primary objective of the trial is to determine if ABL01 treatment are able to reduce and treat onychomycosis. Secondary objectives are to collect safety data, determine if the ABL01 are perceived as easy to use and assess long term effects of the treatment. The endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the 6- or 12-month time-point.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study subjects are randomly assigned to treatment or placebo groups by a predetermined algoritm using sealed envelopes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Men and women above age 18 weighing over 40 kg
- •Present with distal lateral subungual onychomycosis of any of the big toe nails
- •The onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle
排除标准
- •Unable to come for study visits
- •Known allergy to any of the components in ABL01
- •Not willing to participate in the trial or not able to understand the content of the trial
- •Present with proximal subungual onychomycosis or superficial onychomycosis.
- •Present with distal lateral subungual onychomycosis of other nails than the big toe.
- •More than 50 % of the nailbed affected by onychomycosis or the cuticles infected
- •Known conditions (like psoriasis) that cause abnormal nail appearance
- •Nail damage caused by trauma, pressure or other mechanical reasons
- •Currently on immunosuppressive therapy
- •Showing signs of poor peripheral blood circulation
- •Used another topical antifungal treatment within 1 month of screening
- •Used a systemic antifungal treatment within 3 months of screening
- •Participated in any other clinical onychomycosis trial in the previous 3 months
结局指标
主要结局
Number of study subjects with a reduction in infected nail area at 6 months.
时间窗: 6 months
Clinical improvement of the condition is assessed by analyzing changes in infected nail area (in relation to total nail area) due to ABL01 or placebo treatment. Clinical improvement is considered to be a 40% reduction in infected area at the 6 month time period.
次要结局
- Questionnaire regarding subjects opinion of the treatment, nail improvement.(12 months)
- Questionnaire regarding subjects opinion of the treatment, ease of use.(12 months)
- Number of study subjects with treatment-related adverse events(12 months)
- Number of study subjects with a reduction in infected area of the nail(12 months)
- Number of study subjects with clinical cure(12 months)