NCT05115669已完成不适用
Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of Wortie® Freeze Plus in the Treatment of Common Warts and Plantar Warts
Karo Pharma AB1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
研究概览
简要总结
This is a Post-Market clinical Follow-up investigation to evaluate the safety and performed of the medical device Wortie Freeze Plus in the treatment of common and plantar warts.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects.
- •Sex: male or female.
- •Age: 12 years old and above.
- •Subjects presenting at least 1 common wart (present since less than 6 months) on the fingers or back of the hands, and/or plantar wart (40-60% subjects with common wart) of a size less than 1 cm.
- •Subject, including minors having more than 12 years old, having given freely and expressly his/her informed consent.
- •Minor whose legally designated representative have given their free and express informed consent.
- •Subject affiliated to a health social security system.
- •Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision.
- •Major subject who is under guardianship or who is not able to express his consent.
- •Subject in a social or sanitary establishment.
- •Subject suspected to be non-compliant according to the Investigator's judgment
- •Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- •Subject with a cutaneous disease other than common warts, on the studied zone.
- •Subject with a known allergy to one of the components of the investigational device or conductive gel.
- •Subject who has diabetes.
- •Subject having problems with blood circulation or having a blood clotting condition.
- •Subject with immune deficiency or autoimmune disease.
- •Subject presenting more than 10 warts on the body
- •Subject presenting bleeding warts.
- •Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area.
- •Subject having a sensitive, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy skin on or around the treated zone.
- •Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts with hairs growing from them.
- •Subject presenting 2 or more warts adjacent to each other
- •Subject undergoing a topical treatment on the test area or a systemic treatment: anti-inflammatory medication and/or antihistamines during the 2 weeks prior to screening and during the study; or corticosteroids during the 2 weeks prior to screening and during the study; or retinoids and/or immunosuppressors during the 3 months prior to screening and during the study; or any medication stabilized for less than a month
- •Subject who received a treatment of any type on the selected wart during the previous 6 months.
- •Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous months
- •Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study.
- •Subject planning to change her/his life habits during the study.
- •Subject with excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
结局指标
主要结局
Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
时间窗: Day 42
次要结局
- Percentage of subjects with cured wart after 1, 2 and 3 treatments evaluated by the investigator common and plantar warts after 1, 2 and 3 treatments as assessed by the investigator(Day 14, Day 28, Day 42)
- Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end(Day 14, Day 28, Day 42)
- Illustration of the skin aspect by pictures before and after each treatment(Day 0, Day 14, Day 28)
- Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale(Day 0, Day 14, Day 28)
- Percentage of subjects with improved aspect of the wart after 1, 2 and 3 treatments evaluated by the investigator(Day 14, Day 28, Day 42)
- Mean frostbite area diameter after each treatment(Day 0, Day 14, Day 28)
- Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale(Day 14,Day 28, Day 42)
- Collection of adverse events throughout the study(Day 0, Day 14, Day 28, Day 42)
研究者
研究点 (1)
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