2024-514476-40-00招募中4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LVERU®JUNIOR and 2LVERU® on the treatment of warts.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 11
- 主要终点
- Disappearance of warts at the end of treatment (6-month visit)
研究概览
简要总结
Comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients, male or female, aged 3 years and older, - Patients with common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana), - Patients (and/or parents if necessary) having the faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form by the patient (and/or parents if necessary).
排除标准
- •Patients who have received any curative warts treatment in the previous 2 months prior to the study, - Patients who have received any homeopathic treatment in the previous 2 months prior to the study, - Patients under immunosuppressive treatment, - Patients having received immunotherapy or micro-immunotherapy during the last 6 months, - Patients with known lactose intolerance, - Pregnant or breastfeeding women, - Patients who participated in a clinical study in the previous 2-months period, - Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study, - Patients with severe immunodeficiency disease requiring long term treatment or patients under chemotherapy or radiotherapy, - Patients under listed homeopathic or phytotherapy treatment (see protocol), - Patients addicted to or using recreational drugs, - Patient under guardianship and/or curatorship,
结局指标
主要结局
Disappearance of warts at the end of treatment (6-month visit)
Disappearance of warts at the end of treatment (6-month visit)
次要结局
- - Disappearance of warts at 4 months. - Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months and 6 months, - Warts recurrence at 3-month visit post-treatment - Pain evaluation during the study by VAS and consumption of antalgic medication. - Safety: occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
研究者
Clinical Project Manager
Scientific
Labo'Life Belgium
研究点 (11)
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