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
- 发起方
- 入组人数
- 162
- 试验地点
- 8
- 主要终点
- Disappearance of warts at the end of treatment (6-month visit)
研究概览
简要总结
Human papillomavirus (HPV) infection is very common, as most people will experience infection during their lifetime. The most common manifestation of HPV infection is common warts. Common warts may appear at any age.
Conventional treatments can be used to treat warts and they are based on two mechanisms: stimulation of cellular immunity against HPVs or destruction of the lesion. These treatments are based on the location of the wart and the degree of the symptoms.
No specific antiviral therapy is available to cure warts and today, there is no treatment that allows the definitive eradication of the virus.
The 2LVERU® has been available for more than 20 years, and has received a marketing authorization in Belgium by the Federal Agency for Medicines and Health Products (FAMHP). It is used as an immune regulator in the treatment of common warts (verruca vulgaris), flat warts (verruca plana) or plantar warts (verruca plantaris) caused by Human Papillomavirus. Since 2LVERU® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of warts.
The purpose of this placebo-controlled, randomized, double-blind trial is the 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.
详细描述
The study duration will be maximum 45 months with 36 months of inclusion and 9 months of follow-up.
Patients aged 3 years and older who present common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana) during a visit with their dermatologist/general practitioner.
The total number of patients to include will be 162.
Primary objective:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 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 curators, (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
研究组 & 干预措施
2LVERU®/2LVERU® JUNIOR
Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)
干预措施: 2LVERU® or 2LVERU® JUNIOR (Drug)
Placebo
Group N°2: Placebo treatment (6 months of treatment)
干预措施: Placebo (Drug)
结局指标
主要结局
Disappearance of warts at the end of treatment (6-month visit)
时间窗: 6 months
A wart will be considered as disappeared if the colour and texture of the skin has returned to normal and can no longer be felt to the touch.
次要结局
- Disappearance of warts at 4 months.(4 months)
- Warts recurrence at 9 months(9 months)
- Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months(4 months)
- Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.(6 months)
- Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.(6 months)
- Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months(6 months)