A Prospective Single-arm Investigation to Assess the Efficacy, of Topical "Nåva" Foot Cream for 8 Weeks of Treatment in Patients With Mild to Moderate Tinea Pedis Interdigitalis and Heal Cracks, Calluses and/or Dry Feet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Effective clinical treatment rate
研究概览
简要总结
A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month 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
- •Signed Informed Consent Form
- •> 18 years of age
- •Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte
- •Total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe)
- •o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour
- •Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses and dry feet (hyperkeratosis) using a 5-point severity scale (0=absent, 1= mild, 2= moderate, 3= advanced, 4=severe) age
排除标准
- •Patients with negative mycological culture
- •Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms > 16
- •Women pregnant or lactation at time of enrolment
- •Patients using medicinal topical antifungal therapy within 4 weeks prior to study start
- •Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study
- •Treatment with other systemic antifungals within 12 weeks prior to start of study
- •Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study
- •Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
- •Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
结局指标
主要结局
Effective clinical treatment rate
时间窗: Baseline to end of study (8 weeks)
Change of total mean score (TMS): Improvement of 8 clinical signs and symptoms of foot fungus calculated as the total score of all using a 4-point severity scale for each symptom.
次要结局
- Frequency of negative fungal culture(Baseline to end of study (8 weeks))
- Frequency of negative KOH test(Baseline to end of study (8 weeks))
- Tolerability to the device used(Baseline to end of study (8 weeks))
- Other clinical signs and symptoms(Baseline to end of study (8 weeks))
- Dermatology Quality of life(Baseline to end of study (8 weeks))