A Prospective Single-arm Investigation to Assess the Efficacy and Safety After Using BioCool Footcare (Footbath) for 3 Weeks of Treatment in Subjects With Mild to Moderate Symptoms/Signs of Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biocool AB
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Symptoms of foot fungus
研究概览
简要总结
A prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. The investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. Each subject will be treated with the study product, BioCool Footcare (footbath), for 3 weeks. The study duration is estimated to 5 months including recruiting, treatment and follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation:
- •Signed informed consent form
- •> 18 years of age
- •Males and females
- •Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is
- •Score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur.
- •Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe).
- •Patient with confirmed mycological culture
排除标准
- •Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
- •Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading >16 (signs and symptoms)
- •Women pregnant or lactation at time of enrolment
- •Diagnosed with Diabetes Type I or II
- •Topical medicinal antifungal therapy within 4 weeks prior to study start
- •Treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start
- •Treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start
- •Any other open wounds/lesions in the area treated with the Investigational device
- •Participated in another Clinical Investigation/Trial the last 3 months
- •Any other medical condition, judged by the investigator may make follow-up or investigation inappropriate
结局指标
主要结局
Symptoms of foot fungus
时间窗: Baseline to end of study (3 weeks)
Effective treatment rate of the eight clinical signs and symptoms (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe)
次要结局
- Follow-up on heel cracks, calluses and/or dry feet(Baseline to end of study (3 weeks))
- Frequency of negative fungual culture in combination with negative KOH test(Baseline to end of study (3 weeks))
- Adverse Events(Baseline to end of study (3 weeks))
- Dermatology Quality of Life(Baseline to end of study (3 weeks))
- Tolerability assessment to BioCool Footcare (foothbath)(Baseline to end of study (3 weeks))