ISRCTN39469406已完成3 期
Clinical evaluation of the efficacy and safety of Excilor 2-in-1 Wart Treatment in the treatment of verruca vulgaris and verruca plantaris
Medical Brands0 个研究点目标入组 66 人开始时间: 2022年7月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sex: female and/or male
- •2. Age: 45 adults 18-65 years old (inclusive) and 15 children 4-17 years old (inclusive)
- •3. Subjects with at least one selected wart on the hand or foot not older than 1 year and not previously treated and having a diameter of 2 to 5 mm
- •4. Subjects or parents/legal guardians psychologically able to understand the study-related information and to give a written informed consent
- •5. Subjects or parents/legal guardians have given freely and expressly their informed consent
- •6. Subjects or parents/legal guardians able to comply with protocol requirements, as defined in the protocol
- •7. Females of childbearing potential should use a medically accepted contraceptive regimen from at least 12 weeks before the beginning of the study till at least 1 month after study completion
排除标准
- •Population:
- •1. Pregnant or nursing subject or planning a pregnancy during the study (females only)
- •2. Subject who had been deprived of her/his freedom by administrative or legal decision or who is under guardianship
- •3. A subject in a social or sanitary establishment
- •4. A subject in an emergency situation
- •5. A subject suspected to be non-compliant according to the investigator’s judgement
- •Associated pathology:
- •1. A subject having clinically significant dermatological pathologies on the tested area, according to the investigator’s judgment
- •2. A subject suffering from a clinically significant illness, stabilized or evolutionary, according to the investigator’s judgement
- •3. Subjects who are suffering from diabetic and/or have a poor blood circulation
- •4. Subjects presenting skin tags, moles, dark patches of skin, freckles, water warts (mollusca contagiosa), seborrhoeic keratosis (verruca seborrhoica) or exfoliated skin in the to be tested skin area
- •5. Damaged, open and/or inflamed skin in the treated area
- •6. Subjects with a known allergy or sensitivity to one of the products’ components
- •7. Immunosuppressed subjects
- •Previous or ongoing treatment:
- •1. Any treatment which, in the investigator’s judgement, put the patient at undue risk or may interfere with the evaluation of the study results
- •1. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during or within 4-6 weeks after the study
- •2. A patient planning to change her/his life habits during the study (diet, cosmetic products use, sport activity etc)
研究者
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