A Pilot Clinical Investigation in Adults to Evaluate the Safety and Performance of a Class IIa Medical Device for the Treatment of Plantar Warts (Verrucas)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Safety Endpoint
研究概览
简要总结
This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult population. The treatment regime will be topical application of the Verruca treatment to the verruca, identified as the reference, once daily for 4 weeks.
Patient & investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile.
Patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule will be collected via patient diary cards. Furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 & 28 days after starting treatment. Diary cards will completed through-out the investigation.
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
- •Male or female patients aged >18 years
- •Patients with verrucas
- •Patients should be willing to take part, able to understand the information given to them and give written consent
排除标准
- •Patient with more than two areas affected by verrucas on one foot
- •Patient who are actively treating or have treated their wart within the past 8 weeks
- •Patient suspected to be immunocompromised or are taking immunosuppressants
- •Patient who suffer from impaired feeling due to diabetes, peripheral vascular disease or neuropathy.
- •Current participation in another clinical investigation or participation within the last 30 days.
- •Patient with known sensitivity/allergies to the test materials or any of their ingredients.
- •Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the volunteer or affect the outcome of the investigation (as determined from self-reported medical history questionnaire).
- •Patient in a situation which in the view of the investigator could interfere with optimal participation in the investigation or constitute a special risk for these patients.
- •Patient who scar easily or are prone to hypertrophic or Keloid scarring.
- •Patient who have previously had an unfavourable reaction to any products for the feet and which involved swelling of the foot, or a requirement for painkillers or antibiotics.
- •Pregnant and lactating females, or those actively seeking to become pregnant in the next month
研究组 & 干预措施
Medical Device
The Investigational device is a liquid in a delivery system for the treatment of verrucas
干预措施: Medical Device (Device)
结局指标
主要结局
Safety Endpoint
时间窗: 4 weeks
Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
次要结局
- Efficacy endpoint presence/absence of verruca by podiatrist(4 weeks)
- Efficacy endpoint presence/absence of verruca and pain by patient(4 weeks)