Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Course of the disease
研究概览
简要总结
Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.
详细描述
A single-center, single-arm, open-label, phase II clinical trial was conducted with 30 patients divided into two groups: 15 patients with herpes simplex virus type 1 (HSV-1) infections and 15 with herpes simplex virus type 2 (HSV-2) infections. All received topical treatment with Lazolex® Gel four times daily for 10 days. The efficacy and tolerance of the treatment were evaluated on day 10 and day 20 after the study started. In addition, recurrence rates were evaluated before treatment with Lazolex® and after a 4-year follow-up period after treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of acute or chronic herpes simplex mucocutaneous infection,
- •mild course of disease (defined as body temperature <37.2°C and without signs of general infirmity),
- •application of last treatment for herpes simplex infection >3 months,
- •available to cooperate during the study,
- •provision of written informed consent.
排除标准
- •abnormal laboratory results,
- •hypersensitivity to the product or its components,
- •pregnancy or breastfeeding,
- •acute/ chronic renal or liver failure,
- •history of migraine,
- •organic brain lesion,
- •generalized anxiety disorder,
- •blood supply disturbance in the vertebrobasilar pool,
- •stage 3 essential hypertension,
- •concomitant acute or decompensated disease that could affect the study results,
- •intake of acyclovir, antibiotics, immunosuppressants, antimetabolites, or glucocorticosteroids during 3-month period prior to the study,
- •concomitant participation in another clinical trial.
研究组 & 干预措施
HSV-1, HSV-2
All participants were assigned to receive topical treatment with Lazolex® Gel. Patients were given the gel at the end of the screening visit (day 0) by the attending physicians.,e gel was applied to the lesion four times a day over a 10-day period, with the Lrst application at 9 am and the fourth at 9 pm. Patients administered Lazolex® Gel to the a2ected areas themselves.
干预措施: walnut extract (Drug)
结局指标
主要结局
Course of the disease
时间窗: 10 days
Lazolex® Gel was classified as effective if herpes lesions improved or healed after treatment. The median effective time (ET50), defined as the time (in days) needed to reach complete recovery in 50% of the patients, was used as the main variable for Lazolex® Gel efficacy.
Change in outbreak frequency
时间窗: 4 years
Change in outbreaks along time
次要结局
- The degree of patient satisfaction(10 days)
- Number of complaints and symptoms(10 days)